{
"NDC": [
{
"NDCCode": "54973-3075-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3075-2) > 19.8 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3075-02",
"ProductNDC": "54973-3075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Cough 4 Kids",
"NonProprietaryName": "Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HYLAND'S, INC.",
"SubstanceName": "ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; GOLDENSEAL",
"StrengthNumber": "6; 12; 6; 12; 6; 12; 6",
"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": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20080801",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3075-1",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (54973-3075-1) ",
"NDC11Code": "54973-3075-01",
"ProductNDC": "54973-3075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Cough 4 Kids",
"NonProprietaryName": "Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; GOLDENSEAL",
"StrengthNumber": "6; 12; 6; 12; 6; 12; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080801",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of common cold in children, including: ■ runny nose ■ sore throat ■ sneezing ■ cough ■ post nasal drip ■ nasal or chest congestion."
},
{
"NDCCode": "54973-3075-3",
"PackageDescription": "5 mL in 1 POUCH (54973-3075-3) ",
"NDC11Code": "54973-3075-03",
"ProductNDC": "54973-3075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Cough 4 Kids",
"NonProprietaryName": "Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; GOLDENSEAL",
"StrengthNumber": "6; 12; 6; 12; 6; 12; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251029",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of common cold in children, including: ■ runny nose ■ sore throat ■ sneezing ■ cough ■ post nasal drip ■ nasal or chest congestion."
},
{
"NDCCode": "54973-3177-1",
"PackageDescription": "1 KIT in 1 CARTON (54973-3177-1) * 118 mL in 1 BOTTLE, PLASTIC (54973-3098-1) * 118 mL in 1 BOTTLE, PLASTIC (54973-3075-1) ",
"NDC11Code": "54973-3177-01",
"ProductNDC": "54973-3177",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Cold N Cough Day And Night Value Pack",
"NonProprietaryName": "Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, Goldenseal, Strychnos Nux-vomica Seed, Coffee Bean, And Chamomile",
"DosageFormName": "KIT",
"StartMarketingDate": "20131201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hylands Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131201",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3378-1",
"PackageDescription": "1 KIT in 1 CARTON (54973-3378-1) * 118 mL in 1 BOTTLE, PLASTIC (54973-3075-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3375-1) / 118 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3378-01",
"ProductNDC": "54973-3378",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Cold And Cough Daytime And Nighttime",
"NonProprietaryName": "Onion, Calcium Sulfide, Sodium Chloride, Anemone Pulsatilla, Arabica Coffee Bean, Matricaria Chamomilla, Sulfur, Phosphorus And Goldenseal",
"DosageFormName": "KIT",
"StartMarketingDate": "20180608",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland�s Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180608",
"SamplePackage": "N"
},
{
"NDCCode": "10742-3075-1",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10742-3075-1) / 4.2 g in 1 TUBE",
"NDC11Code": "10742-3075-01",
"ProductNDC": "10742-3075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mentholatum Natural Ice Cherry, Spf 15",
"ProprietaryNameSuffix": "Cherry",
"NonProprietaryName": "Dimethicone, Octinoxate, Octisalate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Mentholatum Company",
"SubstanceName": "OCTISALATE; DIMETHICONE; OCTINOXATE",
"StrengthNumber": "50; 10; 75",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "36987-3075-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-3075-2)",
"NDC11Code": "36987-3075-02",
"ProductNDC": "36987-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "California Black Walnut",
"NonProprietaryName": "California Black Walnut",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "JUGLANS CALIFORNICA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [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": "48951-3075-2",
"PackageDescription": "1350 LIQUID in 1 BOTTLE, GLASS (48951-3075-2) ",
"NDC11Code": "48951-3075-02",
"ProductNDC": "48951-3075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chelidonium Colocynthis Special Order",
"NonProprietaryName": "Chelidonium Colocynthis Special Order",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT",
"StrengthNumber": "2; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "53225-3075-2",
"PackageDescription": "60 TABLET in 1 BOTTLE (53225-3075-2) ",
"NDC11Code": "53225-3075-02",
"ProductNDC": "53225-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077882",
"LabelerName": "Terrain Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate."
},
{
"NDCCode": "71335-3075-2",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-3075-2) ",
"NDC11Code": "71335-3075-02",
"ProductNDC": "71335-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078314",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260209",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .",
"Description": "Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol."
},
{
"NDCCode": "0006-3075-02",
"PackageDescription": "4 DOSE PACK in 1 CARTON (0006-3075-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3075-01) ",
"NDC11Code": "00006-3075-02",
"ProductNDC": "0006-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevymis",
"NonProprietaryName": "Letermovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209939",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "LETERMOVIR",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).",
"Description": "PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5."
},
{
"NDCCode": "0006-3075-04",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (0006-3075-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-3075-03) ",
"NDC11Code": "00006-3075-04",
"ProductNDC": "0006-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevymis",
"NonProprietaryName": "Letermovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209939",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "LETERMOVIR",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).",
"Description": "PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5."
},
{
"NDCCode": "0378-3075-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3075-01) ",
"NDC11Code": "00378-3075-01",
"ProductNDC": "0378-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980511",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074947",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980511",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belong to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-Chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive ingredients. colloidal silicon dioxide, magnesium stearate, pregelatinized starch (corn) and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&C Red No. 40, gelatin, red iron oxide, sodium lauryl sulfate and titanium dioxide. The 25 mg capsules also contain FD&C Blue No. 1, D&C Yellow No. 10 and D&C Red No. 28, the 50 mg capsules also contain D&C Yellow No. 10 and D&C Red No. 33 and the 75 mg capsules also contain FD&C Blue No. 1. In addition, the black imprinting ink for the 25 mg, 50 mg and 75 mg capsules contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, pharmaceutical glaze, propylene glycol and synthetic black iron oxide."
},
{
"NDCCode": "53225-3075-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (53225-3075-1) ",
"NDC11Code": "53225-3075-01",
"ProductNDC": "53225-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077882",
"LabelerName": "Terrain Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate."
},
{
"NDCCode": "53225-3075-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (53225-3075-3) ",
"NDC11Code": "53225-3075-03",
"ProductNDC": "53225-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077882",
"LabelerName": "Terrain Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate."
},
{
"NDCCode": "53225-3075-4",
"PackageDescription": "100 TABLET in 1 BOTTLE (53225-3075-4) ",
"NDC11Code": "53225-3075-04",
"ProductNDC": "53225-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077882",
"LabelerName": "Terrain Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate."
},
{
"NDCCode": "53225-3075-5",
"PackageDescription": "120 TABLET in 1 BOTTLE (53225-3075-5) ",
"NDC11Code": "53225-3075-05",
"ProductNDC": "53225-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077882",
"LabelerName": "Terrain Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate."
},
{
"NDCCode": "53225-3075-6",
"PackageDescription": "500 TABLET in 1 BOTTLE (53225-3075-6) ",
"NDC11Code": "53225-3075-06",
"ProductNDC": "53225-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077882",
"LabelerName": "Terrain Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate."
},
{
"NDCCode": "53225-3075-7",
"PackageDescription": "1000 TABLET in 1 BOTTLE (53225-3075-7) ",
"NDC11Code": "53225-3075-07",
"ProductNDC": "53225-3075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077882",
"LabelerName": "Terrain Pharmaceuticals, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate."
},
{
"NDCCode": "54973-0229-2",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-0229-2) ",
"NDC11Code": "54973-0229-02",
"ProductNDC": "54973-0229",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicaid",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19910717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "30; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19910717",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-0232-2",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-0232-2) ",
"NDC11Code": "54973-0232-02",
"ProductNDC": "54973-0232",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnisport",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20000428",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20000428",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-1068-2",
"PackageDescription": "1000 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-1068-2) ",
"NDC11Code": "54973-1068-02",
"ProductNDC": "54973-1068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bioplasma",
"NonProprietaryName": "Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19400101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 3; 3; 3; 3; 3; 3; 6; 6; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19400101",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of symptoms of colds, simple nervous tension, fatigue and headaches."
},
{
"NDCCode": "54973-1069-2",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (54973-1069-2) ",
"NDC11Code": "54973-1069-02",
"ProductNDC": "54973-1069",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biochemic Phosphate",
"NonProprietaryName": "Tribasic Calcium Phosphate, Ferrosoferric Phosphate, Potassium Phosphate, Dibasic, Magnesium Phosphate, Dibasic Trihydrate, And Sodium Phosphate, Dibasic, Heptahydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19790919",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19790919",
"SamplePackage": "N",
"IndicationAndUsage": "Relief of symptoms of nervous exhaustion, irritability and occasional sleeplessness."
},
{
"NDCCode": "54973-1121-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-1121-2) > 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-1121-02",
"ProductNDC": "54973-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calms Forte",
"NonProprietaryName": "Avena Sativa Flowering Top, Chamomile, Humulus Lupulus Stem, Passiflora Incarnata Flower, Calcium Phosphate, Ferrosoferric Phosphate, Potassium Phosphate, Dibasic, Sodium Phosphate, And Magnesium Phosphate, Dibasic Trihydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19601001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; CHAMOMILE; HUMULUS LUPULUS STEM; PASSIFLORA INCARNATA FLOWER; CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "1; 2; 1; 1; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54973-1156-2",
"PackageDescription": "120 mL in 1 BOTTLE, GLASS (54973-1156-2) ",
"NDC11Code": "54973-1156-02",
"ProductNDC": "54973-1156",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicated Oil",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19970217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "54973-2033-2",
"PackageDescription": "1000 TABLET in 1 BOTTLE (54973-2033-2) ",
"NDC11Code": "54973-2033-02",
"ProductNDC": "54973-2033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calc Fluor",
"NonProprietaryName": "Calcium Fluoride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19400101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "54973-2043-2",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (54973-2043-2) ",
"NDC11Code": "54973-2043-02",
"ProductNDC": "54973-2043",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calc Phos",
"NonProprietaryName": "Calcium Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19400101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "CALCIUM PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130426",
"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": "54973-2950-2",
"PackageDescription": "100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-2950-2)",
"NDC11Code": "54973-2950-02",
"ProductNDC": "54973-2950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache",
"NonProprietaryName": "Iris Versicolor Root, Gelsemium Sempervirens Root, Ipecac, And Atropa Belladonna",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19880718",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "IRIS VERSICOLOR ROOT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; ATROPA BELLADONNA",
"StrengthNumber": "3; 3; 3; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-09-01"
},
{
"NDCCode": "54973-2951-2",
"PackageDescription": "100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-2951-2)",
"NDC11Code": "54973-2951-02",
"ProductNDC": "54973-2951",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas",
"NonProprietaryName": "Nutmeg, Asafetida, Strychnos Ignatii Seed, And Lycopodium Clavatum Spore",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19830404",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "NUTMEG; ASAFETIDA; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE",
"StrengthNumber": "3; 3; 3; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-09-13"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54973-3075-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3075-2) > 19.8 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3075-02</NDC11Code>
<ProductNDC>54973-3075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Cough 4 Kids</ProprietaryName>
<NonProprietaryName>Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HYLAND'S, INC.</LabelerName>
<SubstanceName>ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; GOLDENSEAL</SubstanceName>
<StrengthNumber>6; 12; 6; 12; 6; 12; 6</StrengthNumber>
<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>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3075-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (54973-3075-1) </PackageDescription>
<NDC11Code>54973-3075-01</NDC11Code>
<ProductNDC>54973-3075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Cough 4 Kids</ProprietaryName>
<NonProprietaryName>Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; GOLDENSEAL</SubstanceName>
<StrengthNumber>6; 12; 6; 12; 6; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of common cold in children, including: ■ runny nose ■ sore throat ■ sneezing ■ cough ■ post nasal drip ■ nasal or chest congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3075-3</NDCCode>
<PackageDescription>5 mL in 1 POUCH (54973-3075-3) </PackageDescription>
<NDC11Code>54973-3075-03</NDC11Code>
<ProductNDC>54973-3075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Cough 4 Kids</ProprietaryName>
<NonProprietaryName>Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, And Goldenseal</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; GOLDENSEAL</SubstanceName>
<StrengthNumber>6; 12; 6; 12; 6; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of common cold in children, including: ■ runny nose ■ sore throat ■ sneezing ■ cough ■ post nasal drip ■ nasal or chest congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3177-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (54973-3177-1) * 118 mL in 1 BOTTLE, PLASTIC (54973-3098-1) * 118 mL in 1 BOTTLE, PLASTIC (54973-3075-1) </PackageDescription>
<NDC11Code>54973-3177-01</NDC11Code>
<ProductNDC>54973-3177</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Cold N Cough Day And Night Value Pack</ProprietaryName>
<NonProprietaryName>Onion, Calcium Sulfide, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sulfur, Goldenseal, Strychnos Nux-vomica Seed, Coffee Bean, And Chamomile</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20131201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hylands Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3378-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (54973-3378-1) * 118 mL in 1 BOTTLE, PLASTIC (54973-3075-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3375-1) / 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3378-01</NDC11Code>
<ProductNDC>54973-3378</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Cold And Cough Daytime And Nighttime</ProprietaryName>
<NonProprietaryName>Onion, Calcium Sulfide, Sodium Chloride, Anemone Pulsatilla, Arabica Coffee Bean, Matricaria Chamomilla, Sulfur, Phosphorus And Goldenseal</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180608</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland�s Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10742-3075-1</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (10742-3075-1) / 4.2 g in 1 TUBE</PackageDescription>
<NDC11Code>10742-3075-01</NDC11Code>
<ProductNDC>10742-3075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mentholatum Natural Ice Cherry, Spf 15</ProprietaryName>
<ProprietaryNameSuffix>Cherry</ProprietaryNameSuffix>
<NonProprietaryName>Dimethicone, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Mentholatum Company</LabelerName>
<SubstanceName>OCTISALATE; DIMETHICONE; OCTINOXATE</SubstanceName>
<StrengthNumber>50; 10; 75</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-3075-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3075-2)</PackageDescription>
<NDC11Code>36987-3075-02</NDC11Code>
<ProductNDC>36987-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>California Black Walnut</ProprietaryName>
<NonProprietaryName>California Black Walnut</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS CALIFORNICA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [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>48951-3075-2</NDCCode>
<PackageDescription>1350 LIQUID in 1 BOTTLE, GLASS (48951-3075-2) </PackageDescription>
<NDC11Code>48951-3075-02</NDC11Code>
<ProductNDC>48951-3075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chelidonium Colocynthis Special Order</ProprietaryName>
<NonProprietaryName>Chelidonium Colocynthis Special Order</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT</SubstanceName>
<StrengthNumber>2; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53225-3075-2</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (53225-3075-2) </PackageDescription>
<NDC11Code>53225-3075-02</NDC11Code>
<ProductNDC>53225-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077882</ApplicationNumber>
<LabelerName>Terrain Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>71335-3075-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71335-3075-2) </PackageDescription>
<NDC11Code>71335-3075-02</NDC11Code>
<ProductNDC>71335-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078314</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis .</IndicationAndUsage>
<Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows:. Naproxen Tablets, USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>0006-3075-02</NDCCode>
<PackageDescription>4 DOSE PACK in 1 CARTON (0006-3075-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3075-01) </PackageDescription>
<NDC11Code>00006-3075-02</NDC11Code>
<ProductNDC>0006-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevymis</ProprietaryName>
<NonProprietaryName>Letermovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209939</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>LETERMOVIR</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).</IndicationAndUsage>
<Description>PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0006-3075-04</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (0006-3075-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-3075-03) </PackageDescription>
<NDC11Code>00006-3075-04</NDC11Code>
<ProductNDC>0006-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevymis</ProprietaryName>
<NonProprietaryName>Letermovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171108</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209939</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>LETERMOVIR</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: 1 Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). (1.1), 2 Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). (1.2).</IndicationAndUsage>
<Description>PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion. Letermovir has a molecular formula of C29H28F4N4O4 and a molecular weight of 572.55. The chemical name for letermovir is (4S)-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid. Letermovir is very slightly soluble in water. The chemical structure of letermovir is:. PREVYMIS is available as 240 mg and 480 mg tablets. PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. Carnauba wax is added as a polishing agent. PREVYMIS is available as 20 mg and 120 mg packets of oral pellets. PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir. PREVYMIS oral pellets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion. PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial. Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection. The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0378-3075-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3075-01) </PackageDescription>
<NDC11Code>00378-3075-01</NDC11Code>
<ProductNDC>0378-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980511</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074947</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19980511</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules, USP are an antiobsessional drug that belong to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride is 3-Chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride, USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive ingredients. colloidal silicon dioxide, magnesium stearate, pregelatinized starch (corn) and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&C Red No. 40, gelatin, red iron oxide, sodium lauryl sulfate and titanium dioxide. The 25 mg capsules also contain FD&C Blue No. 1, D&C Yellow No. 10 and D&C Red No. 28, the 50 mg capsules also contain D&C Yellow No. 10 and D&C Red No. 33 and the 75 mg capsules also contain FD&C Blue No. 1. In addition, the black imprinting ink for the 25 mg, 50 mg and 75 mg capsules contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, pharmaceutical glaze, propylene glycol and synthetic black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>53225-3075-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53225-3075-1) </PackageDescription>
<NDC11Code>53225-3075-01</NDC11Code>
<ProductNDC>53225-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077882</ApplicationNumber>
<LabelerName>Terrain Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>53225-3075-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (53225-3075-3) </PackageDescription>
<NDC11Code>53225-3075-03</NDC11Code>
<ProductNDC>53225-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077882</ApplicationNumber>
<LabelerName>Terrain Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>53225-3075-4</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (53225-3075-4) </PackageDescription>
<NDC11Code>53225-3075-04</NDC11Code>
<ProductNDC>53225-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077882</ApplicationNumber>
<LabelerName>Terrain Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>53225-3075-5</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (53225-3075-5) </PackageDescription>
<NDC11Code>53225-3075-05</NDC11Code>
<ProductNDC>53225-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077882</ApplicationNumber>
<LabelerName>Terrain Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>53225-3075-6</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (53225-3075-6) </PackageDescription>
<NDC11Code>53225-3075-06</NDC11Code>
<ProductNDC>53225-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077882</ApplicationNumber>
<LabelerName>Terrain Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>53225-3075-7</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (53225-3075-7) </PackageDescription>
<NDC11Code>53225-3075-07</NDC11Code>
<ProductNDC>53225-3075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077882</ApplicationNumber>
<LabelerName>Terrain Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>54973-0229-2</NDCCode>
<PackageDescription>4 TABLET, SOLUBLE in 1 POUCH (54973-0229-2) </PackageDescription>
<NDC11Code>54973-0229-02</NDC11Code>
<ProductNDC>54973-0229</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnicaid</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>30; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910717</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0232-2</NDCCode>
<PackageDescription>4 TABLET, SOLUBLE in 1 POUCH (54973-0232-2) </PackageDescription>
<NDC11Code>54973-0232-02</NDC11Code>
<ProductNDC>54973-0232</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnisport</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000428</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000428</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-1068-2</NDCCode>
<PackageDescription>1000 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-1068-2) </PackageDescription>
<NDC11Code>54973-1068-02</NDC11Code>
<ProductNDC>54973-1068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bioplasma</ProprietaryName>
<NonProprietaryName>Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19400101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 3; 3; 3; 3; 3; 3; 6; 6; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19400101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of symptoms of colds, simple nervous tension, fatigue and headaches.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-1069-2</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (54973-1069-2) </PackageDescription>
<NDC11Code>54973-1069-02</NDC11Code>
<ProductNDC>54973-1069</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biochemic Phosphate</ProprietaryName>
<NonProprietaryName>Tribasic Calcium Phosphate, Ferrosoferric Phosphate, Potassium Phosphate, Dibasic, Magnesium Phosphate, Dibasic Trihydrate, And Sodium Phosphate, Dibasic, Heptahydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19790919</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relief of symptoms of nervous exhaustion, irritability and occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-1121-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-1121-2) > 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-1121-02</NDC11Code>
<ProductNDC>54973-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calms Forte</ProprietaryName>
<NonProprietaryName>Avena Sativa Flowering Top, Chamomile, Humulus Lupulus Stem, Passiflora Incarnata Flower, Calcium Phosphate, Ferrosoferric Phosphate, Potassium Phosphate, Dibasic, Sodium Phosphate, And Magnesium Phosphate, Dibasic Trihydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19601001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; CHAMOMILE; HUMULUS LUPULUS STEM; PASSIFLORA INCARNATA FLOWER; CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>1; 2; 1; 1; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54973-1156-2</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, GLASS (54973-1156-2) </PackageDescription>
<NDC11Code>54973-1156-02</NDC11Code>
<ProductNDC>54973-1156</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnicated Oil</ProprietaryName>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19970217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54973-2033-2</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (54973-2033-2) </PackageDescription>
<NDC11Code>54973-2033-02</NDC11Code>
<ProductNDC>54973-2033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calc Fluor</ProprietaryName>
<NonProprietaryName>Calcium Fluoride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19400101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</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>
</NDC>
<NDC>
<NDCCode>54973-2043-2</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (54973-2043-2) </PackageDescription>
<NDC11Code>54973-2043-02</NDC11Code>
<ProductNDC>54973-2043</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calc Phos</ProprietaryName>
<NonProprietaryName>Calcium Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19400101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>CALCIUM PHOSPHATE</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>20130426</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>54973-2950-2</NDCCode>
<PackageDescription>100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-2950-2)</PackageDescription>
<NDC11Code>54973-2950-02</NDC11Code>
<ProductNDC>54973-2950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache</ProprietaryName>
<NonProprietaryName>Iris Versicolor Root, Gelsemium Sempervirens Root, Ipecac, And Atropa Belladonna</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880718</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>IRIS VERSICOLOR ROOT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; ATROPA BELLADONNA</SubstanceName>
<StrengthNumber>3; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-09-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>54973-2951-2</NDCCode>
<PackageDescription>100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-2951-2)</PackageDescription>
<NDC11Code>54973-2951-02</NDC11Code>
<ProductNDC>54973-2951</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas</ProprietaryName>
<NonProprietaryName>Nutmeg, Asafetida, Strychnos Ignatii Seed, And Lycopodium Clavatum Spore</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830404</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>NUTMEG; ASAFETIDA; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE</SubstanceName>
<StrengthNumber>3; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-09-13</LastUpdate>
</NDC>
</NDCList>