{
"NDC": [
{
"NDCCode": "63083-2049-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-2049-2) ",
"NDC11Code": "63083-2049-02",
"ProductNDC": "63083-2049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Poison Ivy Dermatosis Drops",
"ProprietaryNameSuffix": "2049",
"NonProprietaryName": "Poison Ivy Dermatosis Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "ECHINACEA PURPUREA WHOLE; GRINDELIA HIRSUTULA FLOWERING TOP; RANUNCULUS BULBOSUS WHOLE; URTICA URENS WHOLE; LYTTA VESICATORIA; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; XEROPHYLLUM ASPHODELOIDES WHOLE; CROTON TIGLIUM SEED",
"StrengthNumber": "2; 2; 3; 3; 4; 6; 6; 6; 8",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "36987-2049-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2049-2)",
"NDC11Code": "36987-2049-02",
"ProductNDC": "36987-2049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillium Notatum",
"NonProprietaryName": "Penicillium Notatum",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2049-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-2049-2) ",
"NDC11Code": "37662-2049-02",
"ProductNDC": "37662-2049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ruthenium",
"NonProprietaryName": "Ruthenium",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "RUTHENIUM",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221129",
"SamplePackage": "N"
},
{
"NDCCode": "54973-2049-2",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (54973-2049-2) ",
"NDC11Code": "54973-2049-02",
"ProductNDC": "54973-2049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcium Sulphate",
"NonProprietaryName": "Calcium Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19400101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "CALCIUM SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19400101",
"SamplePackage": "N"
},
{
"NDCCode": "68745-2049-2",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68745-2049-2) > 20 mL in 1 BOTTLE, PUMP",
"NDC11Code": "68745-2049-02",
"ProductNDC": "68745-2049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Les Beiges",
"ProprietaryNameSuffix": "Healthy Glow Foundation Broad Spectrum Spf 25 Sunscreen No 10",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160504",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CHANEL PARFUMS BEAUTE",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "60; 56",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160504",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "71335-2049-2",
"PackageDescription": "120 TABLET in 1 BOTTLE (71335-2049-2) ",
"NDC11Code": "71335-2049-02",
"ProductNDC": "71335-2049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207510",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220228",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains: Oxycodone Hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 · HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "83678-2049-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (83678-2049-2) / 30 mL in 1 BOTTLE (83678-2049-1) ",
"NDC11Code": "83678-2049-02",
"ProductNDC": "83678-2049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Green Envee Sun Shield Serum",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240701",
"EndMarketingDate": "20260701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Green Envee",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "132",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240701",
"EndMarketingDatePackage": "20260701",
"SamplePackage": "N"
},
{
"NDCCode": "0187-2049-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2049-30) ",
"NDC11Code": "00187-2049-30",
"ProductNDC": "0187-2049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021392",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101225",
"SamplePackage": "N",
"IndicationAndUsage": "CARDIZEM LA is a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. (1.1), 2 improving exercise tolerance in patients with chronic stable angina. (1.2).",
"Description": "CARDIZEM® LA (diltiazem hydrochloride) is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.98. CARDIZEM LA is formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ethyl acrylate and methyl methacrylate copolymer dispersion, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, paraffin wax, polydextrose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, simethicone, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide."
},
{
"NDCCode": "0187-2049-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2049-90) ",
"NDC11Code": "00187-2049-90",
"ProductNDC": "0187-2049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem La",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021392",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101225",
"SamplePackage": "N",
"IndicationAndUsage": "CARDIZEM LA is a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. (1.1), 2 improving exercise tolerance in patients with chronic stable angina. (1.2).",
"Description": "CARDIZEM® LA (diltiazem hydrochloride) is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.98. CARDIZEM LA is formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ethyl acrylate and methyl methacrylate copolymer dispersion, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, paraffin wax, polydextrose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, simethicone, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide."
},
{
"NDCCode": "48951-2049-1",
"PackageDescription": "10 AMPULE in 1 BOX (48951-2049-1) > 1 mL in 1 AMPULE",
"NDC11Code": "48951-2049-01",
"ProductNDC": "48951-2049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berberis Prunus",
"NonProprietaryName": "Berberis Prunus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "BERBERIS VULGARIS ROOT; BOS TAURUS NASAL MUCOSA; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; SILICON DIOXIDE; SILVER; SLOE",
"StrengthNumber": "2; 6; 2; 8; 30; 8; 2",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1001-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1001-2) ",
"NDC11Code": "63083-1001-02",
"ProductNDC": "63083-1001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pets",
"ProprietaryNameSuffix": "1001",
"NonProprietaryName": "Pets",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], Dietary Proteins [CS], Feathers [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1002-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1002-2) ",
"NDC11Code": "63083-1002-02",
"ProductNDC": "63083-1002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biting Insect Mix",
"ProprietaryNameSuffix": "1002",
"NonProprietaryName": "Biting Insect Mix",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SOLENOPSIS INVICTA; APIS CERANA WHOLE; PERIPLANETA AUSTRALASIAE; TABANUS NIGROVITTATUS; CTENOCEPHALIDES CANIS; MUSCA DOMESTICA; CULEX PIPIENS; BOMBYX MORI WHOLE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; POLISTES FUSCATUS WHOLE",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Ant Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1003-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1003-2) ",
"NDC11Code": "63083-1003-02",
"ProductNDC": "63083-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Caffeine Mix",
"ProprietaryNameSuffix": "1003",
"NonProprietaryName": "Caffeine Mix",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAFFEINE; COCOA; COFFEE BEAN; HIGH FRUCTOSE CORN SYRUP; TEA LEAF",
"StrengthNumber": "6; 6; 12; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
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"ProductTypeName": "HUMAN OTC DRUG",
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"Status": "Active",
"LastUpdate": "2026-01-09",
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"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1024-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1024-2) ",
"NDC11Code": "63083-1024-02",
"ProductNDC": "63083-1024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Southeast Regional",
"ProprietaryNameSuffix": "1024",
"NonProprietaryName": "Southeast Regional",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACACIA; PLATANUS OCCIDENTALIS BARK; MILLETTIA PINNATA WHOLE; CYNODON DACTYLON WHOLE; BETULA OCCIDENTALIS POLLEN; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; ELM; PLANTAGO LANCEOLATA LEAF; SCHINUS TEREBINTHIFOLIA POLLEN; MEDICAGO SATIVA WHOLE; CHENOPODIUM ALBUM POLLEN; IVA ANGUSTIFOLIA WHOLE; MELALEUCA VIRIDIFLORA WHOLE; JUNIPERUS SCOPULORUM POLLEN; WHITE MULBERRY; QUERCUS KELLOGGII POLLEN; AMARANTHUS HYBRIDUS LEAF; PINUS PONDEROSA POLLEN; AMBROSIA ARTEMISIIFOLIA WHOLE; RUMEX CRISPUS ROOT; SAGE; STENOTAPHRUM SECUNDATUM WHOLE; ENGLISH WALNUT; AMARANTHUS TUBERCULATUS POLLEN; FRAXINUS AMERICANA BARK",
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"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
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"NDCCode": "63083-1025-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1025-2) ",
"NDC11Code": "63083-1025-02",
"ProductNDC": "63083-1025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Airborne",
"ProprietaryNameSuffix": "1025",
"NonProprietaryName": "Airborne",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; BEEF LIVER; HISTAMINE DIHYDROCHLORIDE; FELIS CATUS HAIR; HOUSE DUST; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; MEDICAGO SATIVA WHOLE; FRAXINUS LATIFOLIA WHOLE",
"StrengthNumber": "6; 6; 6; 12; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], House Dust [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized House Dust Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "63083-1026-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-1026-2) ",
"NDC11Code": "63083-1026-02",
"ProductNDC": "63083-1026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eastern Trees",
"ProprietaryNameSuffix": "1026",
"NonProprietaryName": "Eastern Trees",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "FRAXINUS LATIFOLIA WHOLE; MILLETTIA PINNATA WHOLE; BETULA OCCIDENTALIS POLLEN; ELM; CARYA LACINIOSA BARK; ACER PENSYLVANICUM WHOLE; QUERCUS KELLOGGII POLLEN; LIRIODENDRON TULIPIFERA WHOLE; LIQUIDAMBAR STYRACIFLUA RESIN; SYMPHORICARPOS ALBUS FRUIT",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
}
]
}
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<NDC>
<NDCCode>63083-2049-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-2049-2) </PackageDescription>
<NDC11Code>63083-2049-02</NDC11Code>
<ProductNDC>63083-2049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Poison Ivy Dermatosis Drops</ProprietaryName>
<ProprietaryNameSuffix>2049</ProprietaryNameSuffix>
<NonProprietaryName>Poison Ivy Dermatosis Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>ECHINACEA PURPUREA WHOLE; GRINDELIA HIRSUTULA FLOWERING TOP; RANUNCULUS BULBOSUS WHOLE; URTICA URENS WHOLE; LYTTA VESICATORIA; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; XEROPHYLLUM ASPHODELOIDES WHOLE; CROTON TIGLIUM SEED</SubstanceName>
<StrengthNumber>2; 2; 3; 3; 4; 6; 6; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36987-2049-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2049-2)</PackageDescription>
<NDC11Code>36987-2049-02</NDC11Code>
<ProductNDC>36987-2049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillium Notatum</ProprietaryName>
<NonProprietaryName>Penicillium Notatum</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2049-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-2049-2) </PackageDescription>
<NDC11Code>37662-2049-02</NDC11Code>
<ProductNDC>37662-2049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ruthenium</ProprietaryName>
<NonProprietaryName>Ruthenium</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>RUTHENIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-2049-2</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (54973-2049-2) </PackageDescription>
<NDC11Code>54973-2049-02</NDC11Code>
<ProductNDC>54973-2049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcium Sulphate</ProprietaryName>
<NonProprietaryName>Calcium Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19400101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>CALCIUM SULFATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19400101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68745-2049-2</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68745-2049-2) > 20 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>68745-2049-02</NDC11Code>
<ProductNDC>68745-2049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Les Beiges</ProprietaryName>
<ProprietaryNameSuffix>Healthy Glow Foundation Broad Spectrum Spf 25 Sunscreen No 10</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160504</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CHANEL PARFUMS BEAUTE</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>60; 56</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160504</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-2049-2</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (71335-2049-2) </PackageDescription>
<NDC11Code>71335-2049-02</NDC11Code>
<ProductNDC>71335-2049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207510</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets, for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains: Oxycodone Hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 · HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>83678-2049-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (83678-2049-2) / 30 mL in 1 BOTTLE (83678-2049-1) </PackageDescription>
<NDC11Code>83678-2049-02</NDC11Code>
<ProductNDC>83678-2049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Green Envee Sun Shield Serum</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<EndMarketingDate>20260701</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Green Envee</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>132</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0187-2049-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2049-30) </PackageDescription>
<NDC11Code>00187-2049-30</NDC11Code>
<ProductNDC>0187-2049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021392</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDIZEM LA is a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. (1.1), 2 improving exercise tolerance in patients with chronic stable angina. (1.2).</IndicationAndUsage>
<Description>CARDIZEM® LA (diltiazem hydrochloride) is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.98. CARDIZEM LA is formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ethyl acrylate and methyl methacrylate copolymer dispersion, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, paraffin wax, polydextrose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, simethicone, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide.</Description>
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<NDC11Code>00187-2049-90</NDC11Code>
<ProductNDC>0187-2049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem La</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021392</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDIZEM LA is a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. (1.1), 2 improving exercise tolerance in patients with chronic stable angina. (1.2).</IndicationAndUsage>
<Description>CARDIZEM® LA (diltiazem hydrochloride) is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.98. CARDIZEM LA is formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ethyl acrylate and methyl methacrylate copolymer dispersion, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, paraffin wax, polydextrose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, simethicone, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
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<PackageDescription>10 AMPULE in 1 BOX (48951-2049-1) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>48951-2049-01</NDC11Code>
<ProductNDC>48951-2049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berberis Prunus</ProprietaryName>
<NonProprietaryName>Berberis Prunus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT; BOS TAURUS NASAL MUCOSA; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; SILICON DIOXIDE; SILVER; SLOE</SubstanceName>
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<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1001-2) </PackageDescription>
<NDC11Code>63083-1001-02</NDC11Code>
<ProductNDC>63083-1001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pets</ProprietaryName>
<ProprietaryNameSuffix>1001</ProprietaryNameSuffix>
<NonProprietaryName>Pets</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL</SubstanceName>
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<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dander [CS], Dietary Proteins [CS], Dietary Proteins [CS], Feathers [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1002-2) </PackageDescription>
<NDC11Code>63083-1002-02</NDC11Code>
<ProductNDC>63083-1002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biting Insect Mix</ProprietaryName>
<ProprietaryNameSuffix>1002</ProprietaryNameSuffix>
<NonProprietaryName>Biting Insect Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SOLENOPSIS INVICTA; APIS CERANA WHOLE; PERIPLANETA AUSTRALASIAE; TABANUS NIGROVITTATUS; CTENOCEPHALIDES CANIS; MUSCA DOMESTICA; CULEX PIPIENS; BOMBYX MORI WHOLE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; POLISTES FUSCATUS WHOLE</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Ant Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1003-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1003-2) </PackageDescription>
<NDC11Code>63083-1003-02</NDC11Code>
<ProductNDC>63083-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Caffeine Mix</ProprietaryName>
<ProprietaryNameSuffix>1003</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAFFEINE; COCOA; COFFEE BEAN; HIGH FRUCTOSE CORN SYRUP; TEA LEAF</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Methylxanthine [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>63083-1004-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1004-2) </PackageDescription>
<NDC11Code>63083-1004-02</NDC11Code>
<ProductNDC>63083-1004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dairy Mix</ProprietaryName>
<ProprietaryNameSuffix>1004</ProprietaryNameSuffix>
<NonProprietaryName>Dairy Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; BLUE TILAPIA WHOLE; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED; COW MILK FAT; CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED; WHEY; SWISS CHARD; COW MILK; GOAT MILK; HUMAN MILK</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Milk Proteins [CS], Milk Proteins [CS], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1008-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1008-2) </PackageDescription>
<NDC11Code>63083-1008-02</NDC11Code>
<ProductNDC>63083-1008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flowers</ProprietaryName>
<ProprietaryNameSuffix>1008</ProprietaryNameSuffix>
<NonProprietaryName>Flowers</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; CAMELLIA CHEKIANGOLEOSA SEED OIL; DIANTHUS CARYOPHYLLUS WHOLE; KALIMERIS INDICA WHOLE; NARCISSUS POETICUS WHOLE; TOWNSENDIA EXSCAPA WHOLE; GARDENIA JASMINOIDES FRUIT; GENTIANA LUTEA ROOT; GLADIOLUS COMMUNIS WHOLE; LONICERA CANADENSIS WHOLE; C12-17 ALKANE; DELPHINIUM AJACIS SEED; DIANTHUS SUPERBUS FLOWERING TOP; HEDYCHIUM FLAVESCENS WHOLE; LUPINUS ELEGANS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; NERIUM OLEANDER WHOLE; VIOLA TRICOLOR WHOLE; PAEONIA X SUFFRUTICOSA SEED; RUELLIA SIMPLEX WHOLE; ESCHSCHOLZIA CALIFORNICA FLOWERING TOP; SEDUM ROSEUM WHOLE; ANTIRRHINUM MAJUS LEAF; LIRIODENDRON TULIPIFERA WHOLE</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63083-1011-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1011-2) </PackageDescription>
<NDC11Code>63083-1011-02</NDC11Code>
<ProductNDC>63083-1011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nightshade Mix</ProprietaryName>
<ProprietaryNameSuffix>1011</ProprietaryNameSuffix>
<NonProprietaryName>Nightshade Mix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAPSICUM; EGGPLANT; PHYSALIS VIRGINIANA WHOLE; CULTIVATED MUSHROOM; MUSTARD GREENS; PEPPERS; POTATO; TOBACCO LEAF; TOMATO</SubstanceName>
<StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<NDCCode>63083-1012-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1012-2) </PackageDescription>
<NDC11Code>63083-1012-02</NDC11Code>
<ProductNDC>63083-1012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nut Mix</ProprietaryName>
<ProprietaryNameSuffix>1012</ProprietaryNameSuffix>
<NonProprietaryName>Nut Mix</NonProprietaryName>
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