{
"NDC": [
{
"NDCCode": "62795-7006-4",
"PackageDescription": "1 TUBE in 1 CARTON (62795-7006-4) / 85 g in 1 TUBE",
"NDC11Code": "62795-7006-04",
"ProductNDC": "62795-7006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Extra Strength Gel",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana, Baptisia Tinctoria Root, Atropa Belladonna, Bellis Perennis, Calendula Officinalis Flowering Top, Matricaria Recutita, Echinacea Unspecified, Hamamelis Virginiana Root Bark Stem Bark, Hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top And Comfrey Root",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200414",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 4; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200414",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Nerve Pain, Arthritis Pain."
},
{
"NDCCode": "50090-7006-3",
"PackageDescription": "4 CAPSULE in 1 BOTTLE (50090-7006-3) ",
"NDC11Code": "50090-7006-03",
"ProductNDC": "50090-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "50090-7006-4",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (50090-7006-4) ",
"NDC11Code": "50090-7006-04",
"ProductNDC": "50090-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "62795-1021-4",
"PackageDescription": "60 TABLET in 1 BOTTLE (62795-1021-4) ",
"NDC11Code": "62795-1021-04",
"ProductNDC": "62795-1021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bhi Diarrhea",
"NonProprietaryName": "Aloe, Activated Charcoal, Citrullus Colocynthis Fruit Pulp, Cupric Acetate, Ferrum Phosphoricum, Podophyllum, Potentilla Erecta Root, And Veratrum Album Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ALOE; ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; FERRUM PHOSPHORICUM; PODOPHYLLUM; POTENTILLA ERECTA ROOT; VERATRUM ALBUM ROOT",
"StrengthNumber": "4; 12; 6; 6; 10; 6; 4; 5",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2023-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230821",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of mild diarrhea, travelers’ diarrhea, stomach ache."
},
{
"NDCCode": "62795-1033-4",
"PackageDescription": "100 TABLET in 1 BOTTLE (62795-1033-4) ",
"NDC11Code": "62795-1033-04",
"ProductNDC": "62795-1033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T Relief Arthritis",
"NonProprietaryName": "Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221116",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness."
},
{
"NDCCode": "62795-1034-4",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (62795-1034-4) ",
"NDC11Code": "62795-1034-04",
"ProductNDC": "62795-1034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Arnica Montana Whole, Calendula Officinalis Flowering Top, Hamamelis Virginiana Root Bark/stem Bark,baptisia Tinctoria Root, Bellis Perennis Whole, Echinacea Angustifolia Whole,aconitum Napellus Whole,matricaria Chamomilla Whole,achillea Millefolium Whole,atropa Belladonna,hypericum Perforatum Whole,ruta Graveolens Flowering Top And Comfrey Root",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ACONITUM NAPELLUS; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; ARNICA MONTANA; ACHILLEA MILLEFOLIUM WHOLE",
"StrengthNumber": "3; 2; 2; 3; 4; 8; 2; 3; 2; 2; 2; 3; 2",
"StrengthUnit": "[hp_M]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2023-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221116",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Muscle Pain, joint pain, back pain, nerve pain and Arthritis pain."
},
{
"NDCCode": "62795-1041-3",
"PackageDescription": "4 TABLET, CHEWABLE in 1 POUCH (62795-1041-3) ",
"NDC11Code": "62795-1041-03",
"ProductNDC": "62795-1041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Extra Strength",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis Flowering, Hamamelis Virginiana Root Bark/stem, Baptisia Tinctoria Root, Bellis Perennis, Echinacea, Unspecified, Aconitum Napellus, Matricaria Chamomilla, Achillea Millefolium, Atropa Belladonna, Hypericum Perforatum, Ruta Graveolens Flowering Top And Comfrey Root",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; MATRICARIA CHAMOMILLA; ACHILLEA MILLEFOLIUM; ATROPA BELLADONNA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "3; 2; 2; 2; 2; 2; 3; 2; 2; 3; 3; 3; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2023-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Arthritis Pain."
},
{
"NDCCode": "62795-1041-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-1041-4) / 100 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "62795-1041-04",
"ProductNDC": "62795-1041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Extra Strength",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis Flowering, Hamamelis Virginiana Root Bark/stem, Baptisia Tinctoria Root, Bellis Perennis, Echinacea, Unspecified, Aconitum Napellus, Matricaria Chamomilla, Achillea Millefolium, Atropa Belladonna, Hypericum Perforatum, Ruta Graveolens Flowering Top And Comfrey Root",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; MATRICARIA CHAMOMILLA; ACHILLEA MILLEFOLIUM; ATROPA BELLADONNA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "3; 2; 2; 2; 2; 2; 3; 2; 2; 3; 3; 3; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2023-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210407",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Arthritis Pain."
},
{
"NDCCode": "62795-1120-4",
"PackageDescription": "100 TABLET in 1 BOTTLE (62795-1120-4) ",
"NDC11Code": "62795-1120-04",
"ProductNDC": "62795-1120",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hendel Insomnia Relief",
"NonProprietaryName": "Passiflora Incarnata Flowering Top, Ambergris, Scutellaria Lateriflora, Zinc Valerate Dihydrate, Anamirta Cocculus Seed, And Arabica Coffee Bean",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "AMBERGRIS; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; ZINC VALERATE DIHYDRATE",
"StrengthNumber": "6; 12; 12; 2; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160531",
"SamplePackage": "N"
},
{
"NDCCode": "62795-2000-4",
"PackageDescription": "1 KIT in 1 KIT (62795-2000-4) * 50 mL in 1 BOTTLE (62795-2003-4) * 50 mL in 1 BOTTLE (62795-2001-4) * 50 mL in 1 BOTTLE (62795-2002-4) ",
"NDC11Code": "62795-2000-04",
"ProductNDC": "62795-2000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodyanew Multipack",
"NonProprietaryName": "Bodyanew",
"DosageFormName": "KIT",
"StartMarketingDate": "20140830",
"EndMarketingDate": "20220930",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"Status": "Deprecated",
"LastUpdate": "2022-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140830",
"EndMarketingDatePackage": "20220930",
"SamplePackage": "N"
},
{
"NDCCode": "62795-2004-4",
"PackageDescription": "1 KIT in 1 KIT (62795-2004-4) * 50 mL in 1 BOTTLE (62795-2007-4) * 50 mL in 1 BOTTLE (62795-2009-4) * 50 mL in 1 BOTTLE (62795-2008-4) ",
"NDC11Code": "62795-2004-04",
"ProductNDC": "62795-2004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodyanew",
"NonProprietaryName": "Bodyanew",
"DosageFormName": "KIT",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of occasional low energy, minor abdominal bloating, upper respiratory symtoms such as cough, runny nose, urinary pain."
},
{
"NDCCode": "62795-2005-4",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (62795-2005-4) > 50 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "62795-2005-04",
"ProductNDC": "62795-2005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Aconitum Napellus,arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140930",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "3; 3; 2; 3; 2; 2; 2; 2; 3; 2; 4; 8",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Status": "Deprecated",
"LastUpdate": "2018-11-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62795-2006-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-2006-4) > 50 mL in 1 BOTTLE",
"NDC11Code": "62795-2006-04",
"ProductNDC": "62795-2006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana, Baptisia Tinctoria",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ACONITUM NAPELLUS; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS",
"StrengthNumber": "2; 2; 2; 3; 2; 4; 8; 3; 2; 2; 3; 3; 2",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20151201",
"SamplePackage": "N"
},
{
"NDCCode": "62795-2010-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-2010-4) / 50 mL in 1 BOTTLE",
"NDC11Code": "62795-2010-04",
"ProductNDC": "62795-2010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Extra Strength",
"NonProprietaryName": "Calendula Officinalis Flowering Top, Matricaria Recutita, Hamamelis Virginiana Root Bark/stem Bark, Achillea Millefolium, Ruta Graveolens Flowering Top, Comfrey Root, Aconitum Napellus, Echinacea, Unspecified, Baptisia Tinctoria Root, Atropa Belladonna, Arnica Montana, Bellis Perennis And Hypericum Perforatum",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20191105",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ACONITUM NAPELLUS; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM",
"StrengthNumber": "2; 2; 3; 2; 3; 8; 3; 2; 2; 3; 3; 2; 3",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191105",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For the temporary relief of minor: Muscular Pain, Joint Pain, Back Pain, Nerve Pain and Arthritis Pain."
},
{
"NDCCode": "62795-6001-4",
"PackageDescription": "1 KIT in 1 KIT (62795-6001-4) * 100 TABLET in 1 BOTTLE (62795-1029-2) * 50 g in 1 TUBE (62795-7002-7)",
"NDC11Code": "62795-6001-04",
"ProductNDC": "62795-6001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Value Pack",
"NonProprietaryName": "T-relief",
"DosageFormName": "KIT",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura",
"Status": "Deprecated",
"LastUpdate": "2018-04-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62795-7007-4",
"PackageDescription": "85 g in 1 TUBE (62795-7007-4) ",
"NDC11Code": "62795-7007-04",
"ProductNDC": "62795-7007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Extra Strength Cream",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Unspecified, Aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark Stem Bark, Matricaria Chamomilla, Atropa Belladonna, Bellis Perennis, Ruta Graveolens Flowering Top, Baptisia Tinctoria Root, Comfrey Root And Hypericum Perforatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171019",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; ACHILLEA MILLEFOLIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA CHAMOMILLA; ATROPA BELLADONNA; BELLIS PERENNIS; RUTA GRAVEOLENS FLOWERING TOP; BAPTISIA TINCTORIA ROOT; COMFREY ROOT; HYPERICUM PERFORATUM",
"StrengthNumber": "1; 1; 1; 1; 2; 2; 2; 2; 2; 4; 4; 4; 6",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230927",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Nerve Pain Arthritis Pain."
},
{
"NDCCode": "0273-7006-16",
"PackageDescription": "497 g in 1 BOTTLE (0273-7006-16) ",
"NDC11Code": "00273-7006-16",
"ProductNDC": "0273-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perfect Choice",
"NonProprietaryName": "Sodium Fluoride And Hydrofluoric Acid",
"DosageFormName": "GEL",
"RouteName": "DENTAL",
"StartMarketingDate": "20181222",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Young Dental Manufacturing Co 1, LLC.",
"SubstanceName": "SODIUM FLUORIDE; HYDROFLUORIC ACID",
"StrengthNumber": "7.9; 4.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181222",
"SamplePackage": "N",
"IndicationAndUsage": "Topical application of APF gel is indicated in the prevention of dental caries."
},
{
"NDCCode": "50090-7006-0",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (50090-7006-0) ",
"NDC11Code": "50090-7006-00",
"ProductNDC": "50090-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "50090-7006-1",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (50090-7006-1) ",
"NDC11Code": "50090-7006-01",
"ProductNDC": "50090-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "50090-7006-6",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (50090-7006-6) ",
"NDC11Code": "50090-7006-06",
"ProductNDC": "50090-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "50090-7006-7",
"PackageDescription": "42 CAPSULE in 1 BOTTLE (50090-7006-7) ",
"NDC11Code": "50090-7006-07",
"ProductNDC": "50090-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240104",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "52731-7006-2",
"PackageDescription": "1 BOTTLE in 1 BOX (52731-7006-2) > 50 mL in 1 BOTTLE (52731-7006-1) (52731-7006-1)",
"NDC11Code": "52731-7006-02",
"ProductNDC": "52731-7006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Asthma Complex",
"NonProprietaryName": "Berberis Vulgaris, Cactus Grandiflorus, Carbo Vegetabilis, Chelidonium Majus, Cuprum Aceticum, Curare, Dulcamara, Ignatia Amara, Strophanthus Hispidus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nova Homeopathic Therapeutics, Inc.",
"SubstanceName": "BERBERIS VULGARIS FRUIT; SELENICEREUS GRANDIFLORUS FLOWER; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CUPRIC ACETATE; TUBOCURARINE CHLORIDE; SOLANUM DULCAMARA TOP; STRYCHNOS IGNATII SEED; STROPHANTHUS HISPIDUS SEED",
"StrengthNumber": "6; 4; 12; 6; 4; 12; 6; 12; 4",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For oral use only."
},
{
"NDCCode": "53808-0381-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-0381-1)",
"NDC11Code": "53808-0381-01",
"ProductNDC": "53808-0381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078170",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is used."
},
{
"NDCCode": "53808-0712-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-0712-1)",
"NDC11Code": "53808-0712-01",
"ProductNDC": "53808-0712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078170",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is used."
},
{
"NDCCode": "53808-0717-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-0717-1)",
"NDC11Code": "53808-0717-01",
"ProductNDC": "53808-0717",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078170",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is used."
},
{
"NDCCode": "60505-7006-2",
"PackageDescription": "5 POUCH in 1 CARTON (60505-7006-2) / 1 PATCH in 1 POUCH (60505-7006-0) / 72 h in 1 PATCH",
"NDC11Code": "60505-7006-02",
"ProductNDC": "60505-7006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20130404",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077449",
"LabelerName": "Apotex Corp.",
"SubstanceName": "FENTANYL",
"StrengthNumber": "25",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130404",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1)] , reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2). The composition per unit area of all transdermal system sizes is identical. * Nominal delivery rate is 12.5 mcg/hour. ** Nominal delivery rate per hour. The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22H 28N 2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal system is a rectangular unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyethylene/aluminum/polyester film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded."
},
{
"NDCCode": "62795-1003-2",
"PackageDescription": "100 TABLET in 1 BOTTLE (62795-1003-2) ",
"NDC11Code": "62795-1003-02",
"ProductNDC": "62795-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bhi Bodypure",
"NonProprietaryName": ".alpha.-lipoic Acid, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Caffeine, Cholesterol, Juglans Regia Flowering Top, Strychnos Nux-vomica Seed, Kerosene, Frangula Purshiana Bark, Ricinus Communis Seed, Solidago Virgaurea Flowering Top, Urtica Urens, Viola Tricolor, And Alcohol, X-ray Exposed (1000 Rad)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": ".ALPHA.-LIPOIC ACID; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAFFEINE; CHOLESTEROL; JUGLANS REGIA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; KEROSENE; FRANGULA PURSHIANA BARK; RICINUS COMMUNIS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS; VIOLA TRICOLOR; ALCOHOL, X-RAY EXPOSED (1000 RAD)",
"StrengthNumber": "3; 3; 6; 6; 10; 6; 30; 12; 6; 3; 4; 6; 4; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140830",
"SamplePackage": "N"
},
{
"NDCCode": "62795-1003-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-1003-3) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "62795-1003-03",
"ProductNDC": "62795-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bhi Bodypure",
"NonProprietaryName": ".alpha.-lipoic Acid, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Caffeine, Cholesterol, Juglans Regia Flowering Top, Strychnos Nux-vomica Seed, Kerosene, Frangula Purshiana Bark, Ricinus Communis Seed, Solidago Virgaurea Flowering Top, Urtica Urens, Viola Tricolor, And Alcohol, X-ray Exposed (1000 Rad)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140830",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": ".ALPHA.-LIPOIC ACID; ALCOHOL, X-RAY EXPOSED (1000 RAD); AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAFFEINE; CHOLESTEROL; FRANGULA PURSHIANA BARK; JUGLANS REGIA FLOWERING TOP; KEROSENE; RICINUS COMMUNIS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; URTICA URENS; VIOLA TRICOLOR",
"StrengthNumber": "3; 12; 3; 6; 6; 10; 6; 6; 12; 3; 4; 30; 6; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Methylxanthine [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140830",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor fatigue, headache, bloating."
},
{
"NDCCode": "62795-1005-2",
"PackageDescription": "100 TABLET in 1 BOTTLE (62795-1005-2) ",
"NDC11Code": "62795-1005-02",
"ProductNDC": "62795-1005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bhi Constipation",
"NonProprietaryName": "Dioscorea Villosa Tuber, Sodium Chloride, And Strychnos Nux-vomica Seed",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "DIOSCOREA VILLOSA TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "4; 200; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "62795-1005-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-1005-3) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "62795-1005-03",
"ProductNDC": "62795-1005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bhi Constipation",
"NonProprietaryName": "Dioscorea Villosa Tuber, Sodium Chloride, And Strychnos Nux-vomica Seed",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "DIOSCOREA VILLOSA TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "4; 200; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140830",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor constipation, bowel irregularity, bloating."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62795-7006-4</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-7006-4) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-7006-04</NDC11Code>
<ProductNDC>62795-7006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Extra Strength Gel</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana, Baptisia Tinctoria Root, Atropa Belladonna, Bellis Perennis, Calendula Officinalis Flowering Top, Matricaria Recutita, Echinacea Unspecified, Hamamelis Virginiana Root Bark Stem Bark, Hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top And Comfrey Root</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200414</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Nerve Pain, Arthritis Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-7006-3</NDCCode>
<PackageDescription>4 CAPSULE in 1 BOTTLE (50090-7006-3) </PackageDescription>
<NDC11Code>50090-7006-03</NDC11Code>
<ProductNDC>50090-7006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>50090-7006-4</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (50090-7006-4) </PackageDescription>
<NDC11Code>50090-7006-04</NDC11Code>
<ProductNDC>50090-7006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>62795-1021-4</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62795-1021-4) </PackageDescription>
<NDC11Code>62795-1021-04</NDC11Code>
<ProductNDC>62795-1021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bhi Diarrhea</ProprietaryName>
<NonProprietaryName>Aloe, Activated Charcoal, Citrullus Colocynthis Fruit Pulp, Cupric Acetate, Ferrum Phosphoricum, Podophyllum, Potentilla Erecta Root, And Veratrum Album Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ALOE; ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; FERRUM PHOSPHORICUM; PODOPHYLLUM; POTENTILLA ERECTA ROOT; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>4; 12; 6; 6; 10; 6; 4; 5</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of mild diarrhea, travelers’ diarrhea, stomach ache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1033-4</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62795-1033-4) </PackageDescription>
<NDC11Code>62795-1033-04</NDC11Code>
<ProductNDC>62795-1033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T Relief Arthritis</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1034-4</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (62795-1034-4) </PackageDescription>
<NDC11Code>62795-1034-04</NDC11Code>
<ProductNDC>62795-1034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Arnica Montana Whole, Calendula Officinalis Flowering Top, Hamamelis Virginiana Root Bark/stem Bark,baptisia Tinctoria Root, Bellis Perennis Whole, Echinacea Angustifolia Whole,aconitum Napellus Whole,matricaria Chamomilla Whole,achillea Millefolium Whole,atropa Belladonna,hypericum Perforatum Whole,ruta Graveolens Flowering Top And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; ARNICA MONTANA; ACHILLEA MILLEFOLIUM WHOLE</SubstanceName>
<StrengthNumber>3; 2; 2; 3; 4; 8; 2; 3; 2; 2; 2; 3; 2</StrengthNumber>
<StrengthUnit>[hp_M]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Muscle Pain, joint pain, back pain, nerve pain and Arthritis pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1041-3</NDCCode>
<PackageDescription>4 TABLET, CHEWABLE in 1 POUCH (62795-1041-3) </PackageDescription>
<NDC11Code>62795-1041-03</NDC11Code>
<ProductNDC>62795-1041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Extra Strength</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis Flowering, Hamamelis Virginiana Root Bark/stem, Baptisia Tinctoria Root, Bellis Perennis, Echinacea, Unspecified, Aconitum Napellus, Matricaria Chamomilla, Achillea Millefolium, Atropa Belladonna, Hypericum Perforatum, Ruta Graveolens Flowering Top And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; MATRICARIA CHAMOMILLA; ACHILLEA MILLEFOLIUM; ATROPA BELLADONNA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>3; 2; 2; 2; 2; 2; 3; 2; 2; 3; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Arthritis Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1041-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-1041-4) / 100 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-1041-04</NDC11Code>
<ProductNDC>62795-1041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Extra Strength</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis Flowering, Hamamelis Virginiana Root Bark/stem, Baptisia Tinctoria Root, Bellis Perennis, Echinacea, Unspecified, Aconitum Napellus, Matricaria Chamomilla, Achillea Millefolium, Atropa Belladonna, Hypericum Perforatum, Ruta Graveolens Flowering Top And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; MATRICARIA CHAMOMILLA; ACHILLEA MILLEFOLIUM; ATROPA BELLADONNA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>3; 2; 2; 2; 2; 2; 3; 2; 2; 3; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Arthritis Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1120-4</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62795-1120-4) </PackageDescription>
<NDC11Code>62795-1120-04</NDC11Code>
<ProductNDC>62795-1120</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hendel Insomnia Relief</ProprietaryName>
<NonProprietaryName>Passiflora Incarnata Flowering Top, Ambergris, Scutellaria Lateriflora, Zinc Valerate Dihydrate, Anamirta Cocculus Seed, And Arabica Coffee Bean</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>AMBERGRIS; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; ZINC VALERATE DIHYDRATE</SubstanceName>
<StrengthNumber>6; 12; 12; 2; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62795-2000-4</NDCCode>
<PackageDescription>1 KIT in 1 KIT (62795-2000-4) * 50 mL in 1 BOTTLE (62795-2003-4) * 50 mL in 1 BOTTLE (62795-2001-4) * 50 mL in 1 BOTTLE (62795-2002-4) </PackageDescription>
<NDC11Code>62795-2000-04</NDC11Code>
<ProductNDC>62795-2000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodyanew Multipack</ProprietaryName>
<NonProprietaryName>Bodyanew</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140830</StartMarketingDate>
<EndMarketingDate>20220930</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140830</StartMarketingDatePackage>
<EndMarketingDatePackage>20220930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62795-2004-4</NDCCode>
<PackageDescription>1 KIT in 1 KIT (62795-2004-4) * 50 mL in 1 BOTTLE (62795-2007-4) * 50 mL in 1 BOTTLE (62795-2009-4) * 50 mL in 1 BOTTLE (62795-2008-4) </PackageDescription>
<NDC11Code>62795-2004-04</NDC11Code>
<ProductNDC>62795-2004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodyanew</ProprietaryName>
<NonProprietaryName>Bodyanew</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of occasional low energy, minor abdominal bloating, upper respiratory symtoms such as cough, runny nose, urinary pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-2005-4</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (62795-2005-4) > 50 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>62795-2005-04</NDC11Code>
<ProductNDC>62795-2005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus,arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>3; 3; 2; 3; 2; 2; 2; 2; 3; 2; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-2006-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-2006-4) > 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-2006-04</NDC11Code>
<ProductNDC>62795-2006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana, Baptisia Tinctoria</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ACONITUM NAPELLUS; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS</SubstanceName>
<StrengthNumber>2; 2; 2; 3; 2; 4; 8; 3; 2; 2; 3; 3; 2</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62795-2010-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-2010-4) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-2010-04</NDC11Code>
<ProductNDC>62795-2010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Extra Strength</ProprietaryName>
<NonProprietaryName>Calendula Officinalis Flowering Top, Matricaria Recutita, Hamamelis Virginiana Root Bark/stem Bark, Achillea Millefolium, Ruta Graveolens Flowering Top, Comfrey Root, Aconitum Napellus, Echinacea, Unspecified, Baptisia Tinctoria Root, Atropa Belladonna, Arnica Montana, Bellis Perennis And Hypericum Perforatum</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191105</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ACONITUM NAPELLUS; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM</SubstanceName>
<StrengthNumber>2; 2; 3; 2; 3; 8; 3; 2; 2; 3; 3; 2; 3</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For the temporary relief of minor: Muscular Pain, Joint Pain, Back Pain, Nerve Pain and Arthritis Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-6001-4</NDCCode>
<PackageDescription>1 KIT in 1 KIT (62795-6001-4) * 100 TABLET in 1 BOTTLE (62795-1029-2) * 50 g in 1 TUBE (62795-7002-7)</PackageDescription>
<NDC11Code>62795-6001-04</NDC11Code>
<ProductNDC>62795-6001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Value Pack</ProprietaryName>
<NonProprietaryName>T-relief</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-04-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-7007-4</NDCCode>
<PackageDescription>85 g in 1 TUBE (62795-7007-4) </PackageDescription>
<NDC11Code>62795-7007-04</NDC11Code>
<ProductNDC>62795-7007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Extra Strength Cream</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Unspecified, Aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark Stem Bark, Matricaria Chamomilla, Atropa Belladonna, Bellis Perennis, Ruta Graveolens Flowering Top, Baptisia Tinctoria Root, Comfrey Root And Hypericum Perforatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171019</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; ACHILLEA MILLEFOLIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA CHAMOMILLA; ATROPA BELLADONNA; BELLIS PERENNIS; RUTA GRAVEOLENS FLOWERING TOP; BAPTISIA TINCTORIA ROOT; COMFREY ROOT; HYPERICUM PERFORATUM</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 2; 2; 2; 2; 4; 4; 4; 6</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Nerve Pain Arthritis Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0273-7006-16</NDCCode>
<PackageDescription>497 g in 1 BOTTLE (0273-7006-16) </PackageDescription>
<NDC11Code>00273-7006-16</NDC11Code>
<ProductNDC>0273-7006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perfect Choice</ProprietaryName>
<NonProprietaryName>Sodium Fluoride And Hydrofluoric Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20181222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Young Dental Manufacturing Co 1, LLC.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; HYDROFLUORIC ACID</SubstanceName>
<StrengthNumber>7.9; 4.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical application of APF gel is indicated in the prevention of dental caries.</IndicationAndUsage>
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<ProductNDC>50090-7006</ProductNDC>
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<LabelerName>A-S Medication Solutions</LabelerName>
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<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
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<StartMarketingDatePackage>20240104</StartMarketingDatePackage>
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<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
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<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
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<NonProprietaryName>Berberis Vulgaris, Cactus Grandiflorus, Carbo Vegetabilis, Chelidonium Majus, Cuprum Aceticum, Curare, Dulcamara, Ignatia Amara, Strophanthus Hispidus</NonProprietaryName>
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<LabelerName>Nova Homeopathic Therapeutics, Inc.</LabelerName>
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<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For oral use only.</IndicationAndUsage>
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<NDC>
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<ProductNDC>53808-0381</ProductNDC>
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<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
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<StartMarketingDate>20090701</StartMarketingDate>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is used.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is used.</Description>
</NDC>
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<ApplicationNumber>ANDA078170</ApplicationNumber>
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<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is used.</Description>
</NDC>
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<EndMarketingDate>20251231</EndMarketingDate>
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<LabelerName>Apotex Corp.</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1)] , reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2). The composition per unit area of all transdermal system sizes is identical. * Nominal delivery rate is 12.5 mcg/hour. ** Nominal delivery rate per hour. The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22H 28N 2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal system is a rectangular unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyethylene/aluminum/polyester film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded.</Description>
</NDC>
<NDC>
<NDCCode>62795-1003-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62795-1003-2) </PackageDescription>
<NDC11Code>62795-1003-02</NDC11Code>
<ProductNDC>62795-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bhi Bodypure</ProprietaryName>
<NonProprietaryName>.alpha.-lipoic Acid, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Caffeine, Cholesterol, Juglans Regia Flowering Top, Strychnos Nux-vomica Seed, Kerosene, Frangula Purshiana Bark, Ricinus Communis Seed, Solidago Virgaurea Flowering Top, Urtica Urens, Viola Tricolor, And Alcohol, X-ray Exposed (1000 Rad)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>.ALPHA.-LIPOIC ACID; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAFFEINE; CHOLESTEROL; JUGLANS REGIA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; KEROSENE; FRANGULA PURSHIANA BARK; RICINUS COMMUNIS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS; VIOLA TRICOLOR; ALCOHOL, X-RAY EXPOSED (1000 RAD)</SubstanceName>
<StrengthNumber>3; 3; 6; 6; 10; 6; 30; 12; 6; 3; 4; 6; 4; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62795-1003-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-1003-3) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-1003-03</NDC11Code>
<ProductNDC>62795-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bhi Bodypure</ProprietaryName>
<NonProprietaryName>.alpha.-lipoic Acid, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Caffeine, Cholesterol, Juglans Regia Flowering Top, Strychnos Nux-vomica Seed, Kerosene, Frangula Purshiana Bark, Ricinus Communis Seed, Solidago Virgaurea Flowering Top, Urtica Urens, Viola Tricolor, And Alcohol, X-ray Exposed (1000 Rad)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>.ALPHA.-LIPOIC ACID; ALCOHOL, X-RAY EXPOSED (1000 RAD); AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAFFEINE; CHOLESTEROL; FRANGULA PURSHIANA BARK; JUGLANS REGIA FLOWERING TOP; KEROSENE; RICINUS COMMUNIS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; URTICA URENS; VIOLA TRICOLOR</SubstanceName>
<StrengthNumber>3; 12; 3; 6; 6; 10; 6; 6; 12; 3; 4; 30; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Methylxanthine [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140830</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor fatigue, headache, bloating.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1005-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62795-1005-2) </PackageDescription>
<NDC11Code>62795-1005-02</NDC11Code>
<ProductNDC>62795-1005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bhi Constipation</ProprietaryName>
<NonProprietaryName>Dioscorea Villosa Tuber, Sodium Chloride, And Strychnos Nux-vomica Seed</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>DIOSCOREA VILLOSA TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>4; 200; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-1005-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-1005-3) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-1005-03</NDC11Code>
<ProductNDC>62795-1005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bhi Constipation</ProprietaryName>
<NonProprietaryName>Dioscorea Villosa Tuber, Sodium Chloride, And Strychnos Nux-vomica Seed</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>DIOSCOREA VILLOSA TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>4; 200; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor constipation, bowel irregularity, bloating.</IndicationAndUsage>
</NDC>
</NDCList>