{
"NDC": [
{
"NDCCode": "35781-0500-1",
"PackageDescription": "1 TUBE in 1 CARTON (35781-0500-1) > 15 g in 1 TUBE",
"NDC11Code": "35781-0500-01",
"ProductNDC": "35781-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090630",
"MarketingCategoryName": "PREMARKET NOTIFICATION",
"ApplicationNumber": "K092086",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Stage I - IV pressure ulcers. Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies. Diabetic skin ulcers. First and second degree burns. Post-surgical incisions, cuts and abrasions.",
"Description": "A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process. LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula."
},
{
"NDCCode": "35781-0500-3",
"PackageDescription": "1 TUBE in 1 CARTON (35781-0500-3) > 30 g in 1 TUBE",
"NDC11Code": "35781-0500-03",
"ProductNDC": "35781-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090630",
"MarketingCategoryName": "PREMARKET NOTIFICATION",
"ApplicationNumber": "K092086",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Stage I - IV pressure ulcers. Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies. Diabetic skin ulcers. First and second degree burns. Post-surgical incisions, cuts and abrasions.",
"Description": "A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process. LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula."
},
{
"NDCCode": "35781-0500-9",
"PackageDescription": "1 TUBE in 1 CARTON (35781-0500-9) > 90 g in 1 TUBE",
"NDC11Code": "35781-0500-09",
"ProductNDC": "35781-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090630",
"MarketingCategoryName": "PREMARKET NOTIFICATION",
"ApplicationNumber": "K092086",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Stage I - IV pressure ulcers. Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies. Diabetic skin ulcers. First and second degree burns. Post-surgical incisions, cuts and abrasions.",
"Description": "A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process. LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula."
},
{
"NDCCode": "35781-0194-5",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0194-5) > 50 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "35781-0194-05",
"ProductNDC": "35781-0194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranzgel",
"NonProprietaryName": "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE",
"StrengthNumber": "1; 1; 3; 3; 1; 1; 3; 1; 1; 1; 6; 4; 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",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "INDICATIONS AND USAGE. The drug is indicated for the relief of symptoms, including pain and inflammation associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic, edema, post surgical edema, hematoma, general swelling of joints and soft tissues) to areas such as hand, wrist elbow, shoulder, neck, back, knees, ankles, feet and toes.",
"Description": "DESCRIPTION. A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations."
},
{
"NDCCode": "35781-0210-1",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-1) > 10 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "35781-0210-01",
"ProductNDC": "35781-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Speedgel Rx",
"NonProprietaryName": "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL",
"StrengthNumber": "1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.",
"Description": "SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication, SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study)."
},
{
"NDCCode": "35781-0210-2",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-2) > 30 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "35781-0210-02",
"ProductNDC": "35781-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Speedgel Rx",
"NonProprietaryName": "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL",
"StrengthNumber": "1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.",
"Description": "SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication, SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study)."
},
{
"NDCCode": "35781-0210-9",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-9) > 90 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "35781-0210-09",
"ProductNDC": "35781-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Speedgel Rx",
"NonProprietaryName": "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL",
"StrengthNumber": "1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.",
"Description": "SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication, SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study)."
},
{
"NDCCode": "35781-0230-0",
"PackageDescription": "1 TUBE in 1 BOX (35781-0230-0) > 6 mL in 1 TUBE",
"NDC11Code": "35781-0230-00",
"ProductNDC": "35781-0230",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Inflam-x",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinallis, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hamamellis Virginiana, Hypericum Perforatum, Millefolium, Symphytum Officinale, Zingiber Officinale",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100617",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWER; CHAMOMILE; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; COMFREY ROOT; GINGER",
"StrengthNumber": "3; 3; 4; 1; 1; 1; 1; 1; 1; 1; 1; 4; 1",
"StrengthUnit": "[hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "INFLAM-X PRO is a homeopathic topical analgesic gel that contains the ingredients listed below. Homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions.It is an amber colored odorless gel for use externally to control inflammation and reduce pain."
},
{
"NDCCode": "35781-0300-1",
"PackageDescription": "1 TUBE in 1 CARTON (35781-0300-1) > 9.5 g in 1 TUBE",
"NDC11Code": "35781-0300-01",
"ProductNDC": "35781-0300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lido Rx",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150928",
"SamplePackage": "N",
"IndicationAndUsage": "Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain and soreness; pain from neuropathy; local medical procedures, injections and vaccines; relief of pruritis, pruritic eczema, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritis ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.",
"Description": "Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure."
},
{
"NDCCode": "35781-0300-3",
"PackageDescription": "1 TUBE in 1 CARTON (35781-0300-3) > 28.5 g in 1 TUBE",
"NDC11Code": "35781-0300-03",
"ProductNDC": "35781-0300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lido Rx",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150928",
"SamplePackage": "N",
"IndicationAndUsage": "Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain and soreness; pain from neuropathy; local medical procedures, injections and vaccines; relief of pruritis, pruritic eczema, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritis ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.",
"Description": "Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure."
},
{
"NDCCode": "35781-0300-9",
"PackageDescription": "1 TUBE in 1 CARTON (35781-0300-9) > 85.5 g in 1 TUBE",
"NDC11Code": "35781-0300-09",
"ProductNDC": "35781-0300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lido Rx",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150928",
"SamplePackage": "N",
"IndicationAndUsage": "Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain and soreness; pain from neuropathy; local medical procedures, injections and vaccines; relief of pruritis, pruritic eczema, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritis ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.",
"Description": "Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure."
},
{
"NDCCode": "35781-0301-1",
"PackageDescription": "100 POUCH in 1 BOX (35781-0301-1) > 1 mL in 1 POUCH (35781-0301-0) ",
"NDC11Code": "35781-0301-01",
"ProductNDC": "35781-0301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidodose",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Pain relief."
},
{
"NDCCode": "35781-0301-5",
"PackageDescription": "25 POUCH in 1 BOX (35781-0301-5) > 1 mL in 1 POUCH (35781-0301-0) ",
"NDC11Code": "35781-0301-05",
"ProductNDC": "35781-0301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidodose",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Pain relief."
},
{
"NDCCode": "35781-0400-2",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (35781-0400-2) > 15 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "35781-0400-02",
"ProductNDC": "35781-0400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colcigel",
"NonProprietaryName": "Colchicinum 4x",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "COLCHICINE",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/15mL",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "ColciGel® (colchicinum 4X) transdermal gel is an alkaloid indicated for. Treatment and Prophylaxis of Gout Flares in adults.( 1.1) ColciGel® (colchicinum 4X) is not an analgesic medication and should not be used to treat pain from other causes."
},
{
"NDCCode": "35781-0400-4",
"PackageDescription": "2 BOTTLE, DISPENSING in 1 PACKAGE (35781-0400-4) > 30 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "35781-0400-04",
"ProductNDC": "35781-0400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colcigel",
"NonProprietaryName": "Colchicinum 4x",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "COLCHICINE",
"StrengthNumber": "4",
"StrengthUnit": "[hp_X]/15mL",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "ColciGel® (colchicinum 4X) transdermal gel is an alkaloid indicated for. Treatment and Prophylaxis of Gout Flares in adults.( 1.1) ColciGel® (colchicinum 4X) is not an analgesic medication and should not be used to treat pain from other causes."
},
{
"NDCCode": "35781-0600-8",
"PackageDescription": "18 POUCH in 1 CARTON (35781-0600-8) / 1 FILM in 1 POUCH (35781-0600-1) ",
"NDC11Code": "35781-0600-08",
"ProductNDC": "35781-0600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizafilm",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "FILM",
"RouteName": "ORAL",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "Gensco Laboratories LLC",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260427",
"SamplePackage": "N",
"IndicationAndUsage": "RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.",
"Description": "RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin."
},
{
"NDCCode": "35781-0605-8",
"PackageDescription": "18 POUCH in 1 CARTON (35781-0605-8) / 1 FILM in 1 POUCH (35781-0605-1) ",
"NDC11Code": "35781-0605-08",
"ProductNDC": "35781-0605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizafilm",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "FILM",
"RouteName": "ORAL",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "Gensco Laboratories LLC",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260427",
"SamplePackage": "N",
"IndicationAndUsage": "RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.",
"Description": "RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin."
},
{
"NDCCode": "35781-2500-3",
"PackageDescription": "1 TUBE in 1 CARTON (35781-2500-3) > 30 g in 1 TUBE",
"NDC11Code": "35781-2500-03",
"ProductNDC": "35781-2500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Astero",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160501",
"MarketingCategoryName": "PREMARKET NOTIFICATION",
"ApplicationNumber": "K092086",
"LabelerName": "Gensco Laboratories, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0078-0500-58",
"PackageDescription": "14 PACKET in 1 CARTON (0078-0500-58) > 1 GRANULE in 1 PACKET (0078-0500-62)",
"NDC11Code": "00078-0500-58",
"ProductNDC": "0078-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamisil",
"NonProprietaryName": "Terbinafine Hydrochloride",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022071",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "TERBINAFINE HYDROCHLORIDE",
"StrengthNumber": "187.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Allylamine [CS],Allylamine Antifungal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0078-0500-59",
"PackageDescription": "3 CARTON in 1 PACKAGE (0078-0500-59) > 14 PACKET in 1 CARTON (0078-0500-58) > 1 GRANULE in 1 PACKET (0078-0500-62)",
"NDC11Code": "00078-0500-59",
"ProductNDC": "0078-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamisil",
"NonProprietaryName": "Terbinafine Hydrochloride",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022071",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "TERBINAFINE HYDROCHLORIDE",
"StrengthNumber": "187.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Allylamine [CS],Allylamine Antifungal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0135-0500-02",
"PackageDescription": "2 POWDER in 1 PACKAGE (0135-0500-02)",
"NDC11Code": "00135-0500-02",
"ProductNDC": "0135-0500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bc",
"NonProprietaryName": "Aspirin And Caffeine",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "GlaxoSmithKline Consumer Healthcare LP",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "845; 65",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "0135-0500-06",
"PackageDescription": "6 POWDER in 1 PACKAGE (0135-0500-06)",
"NDC11Code": "00135-0500-06",
"ProductNDC": "0135-0500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bc",
"NonProprietaryName": "Aspirin And Caffeine",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "GlaxoSmithKline Consumer Healthcare LP",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "845; 65",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "0135-0500-18",
"PackageDescription": "18 POWDER in 1 CARTON (0135-0500-18)",
"NDC11Code": "00135-0500-18",
"ProductNDC": "0135-0500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bc",
"NonProprietaryName": "Aspirin And Caffeine",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "GlaxoSmithKline Consumer Healthcare LP",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "845; 65",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "0135-0500-24",
"PackageDescription": "24 POWDER in 1 CARTON (0135-0500-24)",
"NDC11Code": "00135-0500-24",
"ProductNDC": "0135-0500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bc",
"NonProprietaryName": "Aspirin And Caffeine",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "GlaxoSmithKline Consumer Healthcare LP",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "845; 65",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "0135-0500-50",
"PackageDescription": "50 POWDER in 1 CARTON (0135-0500-50)",
"NDC11Code": "00135-0500-50",
"ProductNDC": "0135-0500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bc",
"NonProprietaryName": "Aspirin And Caffeine",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "GlaxoSmithKline Consumer Healthcare LP",
"SubstanceName": "ASPIRIN; CAFFEINE",
"StrengthNumber": "845; 65",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "0178-0500-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0178-0500-01) ",
"NDC11Code": "00178-0500-01",
"ProductNDC": "0178-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lithostat",
"NonProprietaryName": "Acetohydroxamic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018749",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "ACETOHYDROXAMIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Urease Inhibitor [EPC], Urease Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19830531",
"SamplePackage": "N"
},
{
"NDCCode": "0187-0500-02",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0187-0500-02)",
"NDC11Code": "00187-0500-02",
"ProductNDC": "0187-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Motofen",
"NonProprietaryName": "Difenoxin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19620714",
"EndMarketingDate": "20141130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017744",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE",
"StrengthNumber": ".025; 1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-12-05"
},
{
"NDCCode": "0224-0500-80",
"PackageDescription": "90 TABLET in 1 BOTTLE (0224-0500-80) ",
"NDC11Code": "00224-0500-80",
"ProductNDC": "0224-0500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konsyl Daily Therapy Fiber",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120312",
"EndMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Konsyl Pharmaceuticals, Inc.",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120312",
"EndMarketingDatePackage": "20190901",
"SamplePackage": "N"
},
{
"NDCCode": "0224-0500-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (0224-0500-90) ",
"NDC11Code": "00224-0500-90",
"ProductNDC": "0224-0500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konsyl Daily Therapy Fiber",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120312",
"EndMarketingDate": "20190901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Konsyl Pharmaceuticals, Inc.",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120312",
"EndMarketingDatePackage": "20190901",
"SamplePackage": "N"
},
{
"NDCCode": "0276-0500-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0276-0500-10) ",
"NDC11Code": "00276-0500-10",
"ProductNDC": "0276-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide Hydrochloride And Clidinium Bromide",
"NonProprietaryName": "Chlordiazepoxide Hydrochloride, Clidinium Bromide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210579",
"LabelerName": "Misemer Pharmaceuticals, Inc",
"SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE",
"StrengthNumber": "5; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Benzodiazepine [EPC], Benzodiazepines [CS], Cholinergic Antagonists [MoA], Decreased Parasympathetic Acetylcholine Activity [PE], Digestive/GI System Activity Alteration [PE], GI Motility Alteration [PE]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200903",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide Hydrochloride and Clidinium Bromide is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.",
"Description": "Chlordiazepoxide Hydrochloride and Clidinium Bromide combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. Each Chlordiazepoxide Hydrochloride and Clidinium Bromide capsule contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients lactose monohydrate, pregelatinized starch, talc. Gelatin capsule shells may contain titanium dioxide with the following dye systems: D&C Yellow #10, FD&C Green #3 and gelatin. Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows. Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is."
}
]
}
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<NDCList>
<NDC>
<NDCCode>35781-0500-1</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35781-0500-1) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>35781-0500-01</NDC11Code>
<ProductNDC>35781-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090630</StartMarketingDate>
<MarketingCategoryName>PREMARKET NOTIFICATION</MarketingCategoryName>
<ApplicationNumber>K092086</ApplicationNumber>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Stage I - IV pressure ulcers. Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies. Diabetic skin ulcers. First and second degree burns. Post-surgical incisions, cuts and abrasions.</IndicationAndUsage>
<Description>A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process. LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>35781-0500-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35781-0500-3) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>35781-0500-03</NDC11Code>
<ProductNDC>35781-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090630</StartMarketingDate>
<MarketingCategoryName>PREMARKET NOTIFICATION</MarketingCategoryName>
<ApplicationNumber>K092086</ApplicationNumber>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Stage I - IV pressure ulcers. Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies. Diabetic skin ulcers. First and second degree burns. Post-surgical incisions, cuts and abrasions.</IndicationAndUsage>
<Description>A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process. LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>35781-0500-9</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35781-0500-9) > 90 g in 1 TUBE</PackageDescription>
<NDC11Code>35781-0500-09</NDC11Code>
<ProductNDC>35781-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090630</StartMarketingDate>
<MarketingCategoryName>PREMARKET NOTIFICATION</MarketingCategoryName>
<ApplicationNumber>K092086</ApplicationNumber>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Stage I - IV pressure ulcers. Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies. Diabetic skin ulcers. First and second degree burns. Post-surgical incisions, cuts and abrasions.</IndicationAndUsage>
<Description>A soothing hydrogel wound dressing that promotes a moist wound environment that is ideal for the healing process. LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>35781-0194-5</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (35781-0194-5) > 50 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>35781-0194-05</NDC11Code>
<ProductNDC>35781-0194</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranzgel</ProprietaryName>
<NonProprietaryName>Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE</SubstanceName>
<StrengthNumber>1; 1; 3; 3; 1; 1; 3; 1; 1; 1; 6; 4; 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>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INDICATIONS AND USAGE. The drug is indicated for the relief of symptoms, including pain and inflammation associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic, edema, post surgical edema, hematoma, general swelling of joints and soft tissues) to areas such as hand, wrist elbow, shoulder, neck, back, knees, ankles, feet and toes.</IndicationAndUsage>
<Description>DESCRIPTION. A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations.</Description>
</NDC>
<NDC>
<NDCCode>35781-0210-1</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-1) > 10 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>35781-0210-01</NDC11Code>
<ProductNDC>35781-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Speedgel Rx</ProprietaryName>
<NonProprietaryName>Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL</SubstanceName>
<StrengthNumber>1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.</IndicationAndUsage>
<Description>SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication, SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study).</Description>
</NDC>
<NDC>
<NDCCode>35781-0210-2</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-2) > 30 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>35781-0210-02</NDC11Code>
<ProductNDC>35781-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Speedgel Rx</ProprietaryName>
<NonProprietaryName>Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL</SubstanceName>
<StrengthNumber>1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.</IndicationAndUsage>
<Description>SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication, SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study).</Description>
</NDC>
<NDC>
<NDCCode>35781-0210-9</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-9) > 90 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>35781-0210-09</NDC11Code>
<ProductNDC>35781-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Speedgel Rx</ProprietaryName>
<NonProprietaryName>Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL</SubstanceName>
<StrengthNumber>1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS], Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], P-Glycoprotein Interactions [MoA], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.</IndicationAndUsage>
<Description>SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically proven to reduce narcotic use. SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication. It contains the following active ingredients: Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS, Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia 1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS, Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS. It also contains the following inactive ingredients: Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified Water & Urea. The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication, SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study).</Description>
</NDC>
<NDC>
<NDCCode>35781-0230-0</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (35781-0230-0) > 6 mL in 1 TUBE</PackageDescription>
<NDC11Code>35781-0230-00</NDC11Code>
<ProductNDC>35781-0230</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Inflam-x</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinallis, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hamamellis Virginiana, Hypericum Perforatum, Millefolium, Symphytum Officinale, Zingiber Officinale</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100617</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWER; CHAMOMILE; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; COMFREY ROOT; GINGER</SubstanceName>
<StrengthNumber>3; 3; 4; 1; 1; 1; 1; 1; 1; 1; 1; 4; 1</StrengthNumber>
<StrengthUnit>[hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INFLAM-X PRO is a homeopathic topical analgesic gel that contains the ingredients listed below. Homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions.It is an amber colored odorless gel for use externally to control inflammation and reduce pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35781-0300-1</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35781-0300-1) > 9.5 g in 1 TUBE</PackageDescription>
<NDC11Code>35781-0300-01</NDC11Code>
<ProductNDC>35781-0300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lido Rx</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain and soreness; pain from neuropathy; local medical procedures, injections and vaccines; relief of pruritis, pruritic eczema, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritis ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.</IndicationAndUsage>
<Description>Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>35781-0300-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35781-0300-3) > 28.5 g in 1 TUBE</PackageDescription>
<NDC11Code>35781-0300-03</NDC11Code>
<ProductNDC>35781-0300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lido Rx</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain and soreness; pain from neuropathy; local medical procedures, injections and vaccines; relief of pruritis, pruritic eczema, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritis ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.</IndicationAndUsage>
<Description>Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>35781-0300-9</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35781-0300-9) > 85.5 g in 1 TUBE</PackageDescription>
<NDC11Code>35781-0300-09</NDC11Code>
<ProductNDC>35781-0300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lido Rx</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain and soreness; pain from neuropathy; local medical procedures, injections and vaccines; relief of pruritis, pruritic eczema, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritis ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.</IndicationAndUsage>
<Description>Each gram of LiDORx® 3% contains Lidocaine Hydrochloride USP 3% (30 mg). Lidocaine Hydrochloride USP is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl), and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>35781-0301-1</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (35781-0301-1) > 1 mL in 1 POUCH (35781-0301-0) </PackageDescription>
<NDC11Code>35781-0301-01</NDC11Code>
<ProductNDC>35781-0301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidodose</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pain relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35781-0301-5</NDCCode>
<PackageDescription>25 POUCH in 1 BOX (35781-0301-5) > 1 mL in 1 POUCH (35781-0301-0) </PackageDescription>
<NDC11Code>35781-0301-05</NDC11Code>
<ProductNDC>35781-0301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidodose</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pain relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35781-0400-2</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (35781-0400-2) > 15 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>35781-0400-02</NDC11Code>
<ProductNDC>35781-0400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colcigel</ProprietaryName>
<NonProprietaryName>Colchicinum 4x</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ColciGel® (colchicinum 4X) transdermal gel is an alkaloid indicated for. Treatment and Prophylaxis of Gout Flares in adults.( 1.1) ColciGel® (colchicinum 4X) is not an analgesic medication and should not be used to treat pain from other causes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35781-0400-4</NDCCode>
<PackageDescription>2 BOTTLE, DISPENSING in 1 PACKAGE (35781-0400-4) > 30 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>35781-0400-04</NDC11Code>
<ProductNDC>35781-0400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colcigel</ProprietaryName>
<NonProprietaryName>Colchicinum 4x</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ColciGel® (colchicinum 4X) transdermal gel is an alkaloid indicated for. Treatment and Prophylaxis of Gout Flares in adults.( 1.1) ColciGel® (colchicinum 4X) is not an analgesic medication and should not be used to treat pain from other causes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35781-0600-8</NDCCode>
<PackageDescription>18 POUCH in 1 CARTON (35781-0600-8) / 1 FILM in 1 POUCH (35781-0600-1) </PackageDescription>
<NDC11Code>35781-0600-08</NDC11Code>
<ProductNDC>35781-0600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizafilm</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>Gensco Laboratories LLC</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.</IndicationAndUsage>
<Description>RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>35781-0605-8</NDCCode>
<PackageDescription>18 POUCH in 1 CARTON (35781-0605-8) / 1 FILM in 1 POUCH (35781-0605-1) </PackageDescription>
<NDC11Code>35781-0605-08</NDC11Code>
<ProductNDC>35781-0605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizafilm</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>Gensco Laboratories LLC</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use: 1 RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks., 2 RizaFilm is not indicated for the preventive treatment of migraine., 3 Safety and effectiveness of RizaFilm have not been established for cluster headache.</IndicationAndUsage>
<Description>RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1 H-1,2,4-triazol-1-ylmethyl)-1 H-indole-3-ethanamine monobenzoate and its structural formula is:. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>35781-2500-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35781-2500-3) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>35781-2500-03</NDC11Code>
<ProductNDC>35781-2500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Astero</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<MarketingCategoryName>PREMARKET NOTIFICATION</MarketingCategoryName>
<ApplicationNumber>K092086</ApplicationNumber>
<LabelerName>Gensco Laboratories, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0078-0500-58</NDCCode>
<PackageDescription>14 PACKET in 1 CARTON (0078-0500-58) > 1 GRANULE in 1 PACKET (0078-0500-62)</PackageDescription>
<NDC11Code>00078-0500-58</NDC11Code>
<ProductNDC>0078-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamisil</ProprietaryName>
<NonProprietaryName>Terbinafine Hydrochloride</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070928</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022071</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>TERBINAFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>187.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Allylamine [CS],Allylamine Antifungal [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022071</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>TERBINAFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>187.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Allylamine [CS],Allylamine Antifungal [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
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<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<ProductNDC>0135-0500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bc</ProprietaryName>
<NonProprietaryName>Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100608</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare LP</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>845; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
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<PackageDescription>6 POWDER in 1 PACKAGE (0135-0500-06)</PackageDescription>
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<ProductNDC>0135-0500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bc</ProprietaryName>
<NonProprietaryName>Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100608</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare LP</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>845; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
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<ProductNDC>0135-0500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bc</ProprietaryName>
<NonProprietaryName>Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100608</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare LP</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>845; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0135-0500-24</NDCCode>
<PackageDescription>24 POWDER in 1 CARTON (0135-0500-24)</PackageDescription>
<NDC11Code>00135-0500-24</NDC11Code>
<ProductNDC>0135-0500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bc</ProprietaryName>
<NonProprietaryName>Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100608</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare LP</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>845; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0135-0500-50</NDCCode>
<PackageDescription>50 POWDER in 1 CARTON (0135-0500-50)</PackageDescription>
<NDC11Code>00135-0500-50</NDC11Code>
<ProductNDC>0135-0500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bc</ProprietaryName>
<NonProprietaryName>Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100608</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare LP</LabelerName>
<SubstanceName>ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>845; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0178-0500-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0178-0500-01) </PackageDescription>
<NDC11Code>00178-0500-01</NDC11Code>
<ProductNDC>0178-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lithostat</ProprietaryName>
<NonProprietaryName>Acetohydroxamic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018749</ApplicationNumber>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>ACETOHYDROXAMIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Urease Inhibitor [EPC], Urease Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0187-0500-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0187-0500-02)</PackageDescription>
<NDC11Code>00187-0500-02</NDC11Code>
<ProductNDC>0187-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Motofen</ProprietaryName>
<NonProprietaryName>Difenoxin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19620714</StartMarketingDate>
<EndMarketingDate>20141130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017744</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.025; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
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<Status>Deprecated</Status>
<LastUpdate>2014-12-05</LastUpdate>
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<ProductNDC>0224-0500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
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<EndMarketingDate>20190901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Konsyl Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<EndMarketingDatePackage>20190901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductNDC>0224-0500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120312</StartMarketingDate>
<EndMarketingDate>20190901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Konsyl Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<EndMarketingDatePackage>20190901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0276-0500-10</NDCCode>
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<NDC11Code>00276-0500-10</NDC11Code>
<ProductNDC>0276-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide Hydrochloride And Clidinium Bromide</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide Hydrochloride, Clidinium Bromide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210579</ApplicationNumber>
<LabelerName>Misemer Pharmaceuticals, Inc</LabelerName>
<SubstanceName>CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Benzodiazepine [EPC], Benzodiazepines [CS], Cholinergic Antagonists [MoA], Decreased Parasympathetic Acetylcholine Activity [PE], Digestive/GI System Activity Alteration [PE], GI Motility Alteration [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide Hydrochloride and Clidinium Bromide is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.</IndicationAndUsage>
<Description>Chlordiazepoxide Hydrochloride and Clidinium Bromide combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. Each Chlordiazepoxide Hydrochloride and Clidinium Bromide capsule contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients lactose monohydrate, pregelatinized starch, talc. Gelatin capsule shells may contain titanium dioxide with the following dye systems: D&C Yellow #10, FD&C Green #3 and gelatin. Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows. Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is.</Description>
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