{
"NDC": [
{
"NDCCode": "54973-2956-6",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-2956-6) / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-2956-06",
"ProductNDC": "54973-2956",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Consumer Health Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [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": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "63629-2956-6",
"PackageDescription": "6 TABLET in 1 BOTTLE (63629-2956-6) ",
"NDC11Code": "63629-2956-06",
"ProductNDC": "63629-2956",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triazolam",
"NonProprietaryName": "Triazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074224",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TRIAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N"
},
{
"NDCCode": "68071-2956-6",
"PackageDescription": "6 CAPSULE in 1 BOTTLE (68071-2956-6) ",
"NDC11Code": "68071-2956-06",
"ProductNDC": "68071-2956",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"NonProprietaryName": "Nitrofurantoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208516",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230328",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) and other antibacterial drugs,Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin Capsules , USP (monohydrate/macrocrystals)is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, Opacode ® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "54973-2956-1",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-2956-1) / 50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-2956-01",
"ProductNDC": "54973-2956",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Consumer Health Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [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": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "54973-2956-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-2956-2) / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-2956-02",
"ProductNDC": "54973-2956",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Consumer Health Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [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": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "54973-2956-3",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-2956-3) ",
"NDC11Code": "54973-2956-03",
"ProductNDC": "54973-2956",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Consumer Health Inc.",
"SubstanceName": "ACONITUM NAPELLUS; CINCHONA OFFICINALIS BARK; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "6; 3; 6; 6; 3; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [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": "2023-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-2956-4",
"PackageDescription": "4 PACKET in 1 CARTON (54973-2956-4) / 4 TABLET, SOLUBLE in 1 PACKET",
"NDC11Code": "54973-2956-04",
"ProductNDC": "54973-2956",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Consumer Health Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [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": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "54973-1068-6",
"PackageDescription": "8 TABLET, SOLUBLE in 1 PACKET (54973-1068-6) ",
"NDC11Code": "54973-1068-06",
"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",
"SubstanceName": "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; SILICON DIOXIDE",
"StrengthNumber": "6; 3; 3; 3; 3; 3; 3; 3; 6; 3; 3; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "54973-3093-6",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-3093-6) ",
"NDC11Code": "54973-3093-06",
"ProductNDC": "54973-3093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps Pm",
"NonProprietaryName": "Oyster Shell Calcium Carbonate, Crude, Causticum, Matricaria Recutita, Cinchona Officinalis Bark, Copper, Lycopodium Clavatum Spore, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, Silicon Dioxide, And Sulfur",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COPPER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR",
"StrengthNumber": "12; 12; 6; 3; 12; 12; 6; 6; 12; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [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": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "Y",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of pain or cramps in lower body, legs, calves, feet or toes with accompanying occasional sleeplessness or disrupted sleep."
},
{
"NDCCode": "54973-3156-2",
"PackageDescription": "6 POWDER in 1 CARTON (54973-3156-2) ",
"NDC11Code": "54973-3156-02",
"ProductNDC": "54973-3156",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Defend Severe Cold And Flu",
"NonProprietaryName": "Aconitum Napellus Root, Cairina Moschata Heart/liver Autolysate, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ACONITUM NAPELLUS ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE",
"StrengthNumber": "6; 200; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130401",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3158-4",
"PackageDescription": "6 TABLET, SOLUBLE in 1 PACKET (54973-3158-4) ",
"NDC11Code": "54973-3158-04",
"ProductNDC": "54973-3158",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tiny Cold",
"NonProprietaryName": "Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20111228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE",
"StrengthNumber": "6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20111228",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-3164-2",
"PackageDescription": "6 TABLET in 1 POUCH (54973-3164-2)",
"NDC11Code": "54973-3164-02",
"ProductNDC": "54973-3164",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Complete Cold N Flu 4 Kids",
"NonProprietaryName": "Anas Platyrhynchos Feather, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ANAS PLATYRHYNCHOS FEATHER; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODATE",
"StrengthNumber": "200; 3; 3; 3; 6; 3",
"StrengthUnit": "[hp_C]/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": "54973-3174-1",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3174-1) > 29.6 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3174-01",
"ProductNDC": "54973-3174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Gas Drops",
"NonProprietaryName": "Silver Nitrate, Ferula Sumbul Root, Activated Charcoal, Chamomile, Cinchona Officinalis Bark, Citrullus Colocynthis Fruit, Lycopodium Clavatum Spore, Nutmeg, And Sepia Officinalis Juice",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140115",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ACTIVATED CHARCOAL; CHAMOMILE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT; FERULA SUMBUL ROOT; LYCOPODIUM CLAVATUM SPORE; NUTMEG; SEPIA OFFICINALIS JUICE; SILVER NITRATE",
"StrengthNumber": "12; 6; 6; 6; 6; 30; 6; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140115",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves the symptoms of gas, stomach pressure and pain, swollen tummy, restlessness, crying, burping, fussiness, groaning, gas discomfort, colic, constipation, disturbed sleep, hard tummy, and bloating."
},
{
"NDCCode": "54973-3197-2",
"PackageDescription": "6 TABLET in 1 PACKET (54973-3197-2)",
"NDC11Code": "54973-3197-02",
"ProductNDC": "54973-3197",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Teething",
"NonProprietaryName": "Tribasic Calcium Phosphate, Matricaria Recutita, Arabica Coffee Bean, Atropa Belladonna, Magnesium Phosphate, Dibasic Trihydrate, Silicon Dioxide, And Rheum Officinale Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140926",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; ATROPA BELLADONNA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE; RHEUM OFFICINALE ROOT",
"StrengthNumber": "6; 6; 6; 6; 6; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "54973-3252-2",
"PackageDescription": "6 TABLET in 1 PACKET (54973-3252-2) ",
"NDC11Code": "54973-3252-02",
"ProductNDC": "54973-3252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Nighttime Tiny Cold",
"NonProprietaryName": "Matricaria Recutita, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE",
"StrengthNumber": "6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151228",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3308-2",
"PackageDescription": "6 TABLET in 1 PACKET (54973-3308-2) ",
"NDC11Code": "54973-3308-02",
"ProductNDC": "54973-3308",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Calming",
"NonProprietaryName": "Matricaria Recutita, Arabica Coffee Bean, Strychnos Ignatii Seed, Lycopodium Clavatum Spore, Sodium Chloride, Platinum, Anemone Pulsatilla, And Sulfur",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170120",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "MATRICARIA RECUTITA; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PLATINUM; ANEMONE PULSATILLA; SULFUR",
"StrengthNumber": "6; 6; 30; 30; 6; 30; 6; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170120",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3315-3",
"PackageDescription": "6 g in 1 PACKET (54973-3315-3) ",
"NDC11Code": "54973-3315-03",
"ProductNDC": "54973-3315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Oral Pain Relief",
"NonProprietaryName": "Oyster Shell Calcium Carbonate, Crude, Tribasic Calcium Phosphate, Arabica Coffee Bean, Arnica Montana, Ferrum Phosphoricum And Matricaria Chamomilla",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170817",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HYLAND'S",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; ARABICA COFFEE BEAN; ARNICA MONTANA; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM",
"StrengthNumber": "12; 12; 6; 30; 12; 12",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170817",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-3316-3",
"PackageDescription": "6 g in 1 PACKET (54973-3316-3) ",
"NDC11Code": "54973-3316-03",
"ProductNDC": "54973-3316",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Oral Pain Relief",
"NonProprietaryName": "Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum And Matricaria Chamomilla",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM",
"StrengthNumber": "12; 6; 30; 12; 12; 12",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2021-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "54973-3324-4",
"PackageDescription": "6 g in 1 PACKET (54973-3324-4) ",
"NDC11Code": "54973-3324-04",
"ProductNDC": "54973-3324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Nighttime Oral Pain Relief",
"NonProprietaryName": "Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean And Oyster Shell Calcium Carbonate, Crude",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170817",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "HYLAND'S",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; SILICON DIOXIDE; ARNICA MONTANA; FERROSOFERRIC PHOSPHATE; ARABICA COFFEE BEAN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "12; 12; 12; 12; 30; 12; 6; 12",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170817",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-3325-3",
"PackageDescription": "6 g in 1 PACKET (54973-3325-3) ",
"NDC11Code": "54973-3325-03",
"ProductNDC": "54973-3325",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Oral Pain Relief Nighttime",
"NonProprietaryName": "Arnica Montana,tribasic Calcium Phosphate,silicon Dioxide,matricaria Chamomilla,ferrum Phosphoricum,arabica Coffee Bean,magnesium Phosphate, Dibasic Trihydrate And Oyster Shell Calcium Carbonate, Crude",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ARABICA COFFEE BEAN; FERRUM PHOSPHORICUM; SILICON DIOXIDE; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA",
"StrengthNumber": "12; 12; 6; 12; 12; 30; 12; 12",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2021-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "54973-3383-2",
"PackageDescription": "6 TABLET in 1 PACKET (54973-3383-2) ",
"NDC11Code": "54973-3383-02",
"ProductNDC": "54973-3383",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Leg Pain Relief",
"NonProprietaryName": "Tribasic Calcium Phosphate, Arnica Montana, Oyster Shell Calcium Carbonate, Crude, Copper, Eupatorium Perfoliatum Flowering Top, Magnesium Phosphate, Dibasic Trihydrate, Phosphorus, Guaiacum Officinale Resin And Phosphoric Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COPPER; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; PHOSPHORUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORIC ACID",
"StrengthNumber": "12; 30; 12; 12; 30; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-3391-1",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3391-1) > 29.6 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3391-01",
"ProductNDC": "54973-3391",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baby Oral Pain Relief Drops",
"NonProprietaryName": "Ferrosoferric Phosphate,tribasic Calcium Phosphate,oyster Shell Calcium Carbonate,crude,arnica Montana,arabica Coffee Bean And Matricaria Chamomilla",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190124",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; ARABICA COFFEE BEAN; MATRICARIA CHAMOMILLA",
"StrengthNumber": "30; 12; 12; 12; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190124",
"SamplePackage": "N"
},
{
"NDCCode": "68071-2956-2",
"PackageDescription": "2 CAPSULE in 1 BOTTLE (68071-2956-2) ",
"NDC11Code": "68071-2956-02",
"ProductNDC": "68071-2956",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin",
"NonProprietaryName": "Nitrofurantoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208516",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230328",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) and other antibacterial drugs,Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin Capsules , USP (monohydrate/macrocrystals)is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, Opacode ® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "54973-0229-1",
"PackageDescription": "50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-0229-1) ",
"NDC11Code": "54973-0229-01",
"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": "19970717",
"SamplePackage": "N"
},
{
"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": "54973-0229-3",
"PackageDescription": "4 POUCH in 1 CARTON (54973-0229-3) > 4 TABLET, SOLUBLE in 1 POUCH",
"NDC11Code": "54973-0229-03",
"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": "N"
},
{
"NDCCode": "54973-0232-1",
"PackageDescription": "50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-0232-1) ",
"NDC11Code": "54973-0232-01",
"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": "N"
},
{
"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",
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<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
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<IndicationAndUsage>■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
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<PackageDescription>6 TABLET in 1 BOTTLE (63629-2956-6) </PackageDescription>
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<ProductNDC>63629-2956</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triazolam</ProprietaryName>
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<StartMarketingDate>20181029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074224</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TRIAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-03-07</LastUpdate>
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<NDC>
<NDCCode>68071-2956-6</NDCCode>
<PackageDescription>6 CAPSULE in 1 BOTTLE (68071-2956-6) </PackageDescription>
<NDC11Code>68071-2956-06</NDC11Code>
<ProductNDC>68071-2956</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<NonProprietaryName>Nitrofurantoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208516</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
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<IndicationAndUsage>Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) and other antibacterial drugs,Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin Capsules , USP (monohydrate/macrocrystals)is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, Opacode ® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC11Code>54973-2956-01</NDC11Code>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Consumer Health Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [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>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-2956-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-2956-2) / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-2956-02</NDC11Code>
<ProductNDC>54973-2956</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Consumer Health Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [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>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-2956-3</NDCCode>
<PackageDescription>4 TABLET, SOLUBLE in 1 POUCH (54973-2956-3) </PackageDescription>
<NDC11Code>54973-2956-03</NDC11Code>
<ProductNDC>54973-2956</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Consumer Health Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; CINCHONA OFFICINALIS BARK; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>6; 3; 6; 6; 3; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [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>2023-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-2956-4</NDCCode>
<PackageDescription>4 PACKET in 1 CARTON (54973-2956-4) / 4 TABLET, SOLUBLE in 1 PACKET</PackageDescription>
<NDC11Code>54973-2956-04</NDC11Code>
<ProductNDC>54973-2956</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Consumer Health Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [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>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieves the symptoms of. ■ stiffness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-1068-6</NDCCode>
<PackageDescription>8 TABLET, SOLUBLE in 1 PACKET (54973-1068-6) </PackageDescription>
<NDC11Code>54973-1068-06</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</LabelerName>
<SubstanceName>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; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 3; 3; 3; 3; 3; 3; 3; 6; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54973-3093-6</NDCCode>
<PackageDescription>4 TABLET, SOLUBLE in 1 POUCH (54973-3093-6) </PackageDescription>
<NDC11Code>54973-3093-06</NDC11Code>
<ProductNDC>54973-3093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps Pm</ProprietaryName>
<NonProprietaryName>Oyster Shell Calcium Carbonate, Crude, Causticum, Matricaria Recutita, Cinchona Officinalis Bark, Copper, Lycopodium Clavatum Spore, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, Silicon Dioxide, And Sulfur</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COPPER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR</SubstanceName>
<StrengthNumber>12; 12; 6; 3; 12; 12; 6; 6; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [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>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of pain or cramps in lower body, legs, calves, feet or toes with accompanying occasional sleeplessness or disrupted sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3156-2</NDCCode>
<PackageDescription>6 POWDER in 1 CARTON (54973-3156-2) </PackageDescription>
<NDC11Code>54973-3156-02</NDC11Code>
<ProductNDC>54973-3156</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Defend Severe Cold And Flu</ProprietaryName>
<NonProprietaryName>Aconitum Napellus Root, Cairina Moschata Heart/liver Autolysate, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ACONITUM NAPELLUS ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>6; 200; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3158-4</NDCCode>
<PackageDescription>6 TABLET, SOLUBLE in 1 PACKET (54973-3158-4) </PackageDescription>
<NDC11Code>54973-3158-04</NDC11Code>
<ProductNDC>54973-3158</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tiny Cold</ProprietaryName>
<NonProprietaryName>Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111228</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3164-2</NDCCode>
<PackageDescription>6 TABLET in 1 POUCH (54973-3164-2)</PackageDescription>
<NDC11Code>54973-3164-02</NDC11Code>
<ProductNDC>54973-3164</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Complete Cold N Flu 4 Kids</ProprietaryName>
<NonProprietaryName>Anas Platyrhynchos Feather, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ANAS PLATYRHYNCHOS FEATHER; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODATE</SubstanceName>
<StrengthNumber>200; 3; 3; 3; 6; 3</StrengthNumber>
<StrengthUnit>[hp_C]/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>54973-3174-1</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3174-1) > 29.6 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3174-01</NDC11Code>
<ProductNDC>54973-3174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Gas Drops</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Ferula Sumbul Root, Activated Charcoal, Chamomile, Cinchona Officinalis Bark, Citrullus Colocynthis Fruit, Lycopodium Clavatum Spore, Nutmeg, And Sepia Officinalis Juice</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140115</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; CHAMOMILE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT; FERULA SUMBUL ROOT; LYCOPODIUM CLAVATUM SPORE; NUTMEG; SEPIA OFFICINALIS JUICE; SILVER NITRATE</SubstanceName>
<StrengthNumber>12; 6; 6; 6; 6; 30; 6; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves the symptoms of gas, stomach pressure and pain, swollen tummy, restlessness, crying, burping, fussiness, groaning, gas discomfort, colic, constipation, disturbed sleep, hard tummy, and bloating.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3197-2</NDCCode>
<PackageDescription>6 TABLET in 1 PACKET (54973-3197-2)</PackageDescription>
<NDC11Code>54973-3197-02</NDC11Code>
<ProductNDC>54973-3197</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Teething</ProprietaryName>
<NonProprietaryName>Tribasic Calcium Phosphate, Matricaria Recutita, Arabica Coffee Bean, Atropa Belladonna, Magnesium Phosphate, Dibasic Trihydrate, Silicon Dioxide, And Rheum Officinale Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140926</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; ATROPA BELLADONNA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE; RHEUM OFFICINALE ROOT</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 12; 12</StrengthNumber>
<StrengthUnit>[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>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>54973-3252-2</NDCCode>
<PackageDescription>6 TABLET in 1 PACKET (54973-3252-2) </PackageDescription>
<NDC11Code>54973-3252-02</NDC11Code>
<ProductNDC>54973-3252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Nighttime Tiny Cold</ProprietaryName>
<NonProprietaryName>Matricaria Recutita, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE</SubstanceName>
<StrengthNumber>6; 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>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3308-2</NDCCode>
<PackageDescription>6 TABLET in 1 PACKET (54973-3308-2) </PackageDescription>
<NDC11Code>54973-3308-02</NDC11Code>
<ProductNDC>54973-3308</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Calming</ProprietaryName>
<NonProprietaryName>Matricaria Recutita, Arabica Coffee Bean, Strychnos Ignatii Seed, Lycopodium Clavatum Spore, Sodium Chloride, Platinum, Anemone Pulsatilla, And Sulfur</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170120</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>MATRICARIA RECUTITA; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PLATINUM; ANEMONE PULSATILLA; SULFUR</SubstanceName>
<StrengthNumber>6; 6; 30; 30; 6; 30; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3315-3</NDCCode>
<PackageDescription>6 g in 1 PACKET (54973-3315-3) </PackageDescription>
<NDC11Code>54973-3315-03</NDC11Code>
<ProductNDC>54973-3315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Oral Pain Relief</ProprietaryName>
<NonProprietaryName>Oyster Shell Calcium Carbonate, Crude, Tribasic Calcium Phosphate, Arabica Coffee Bean, Arnica Montana, Ferrum Phosphoricum And Matricaria Chamomilla</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HYLAND'S</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; ARABICA COFFEE BEAN; ARNICA MONTANA; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM</SubstanceName>
<StrengthNumber>12; 12; 6; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170817</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3316-3</NDCCode>
<PackageDescription>6 g in 1 PACKET (54973-3316-3) </PackageDescription>
<NDC11Code>54973-3316-03</NDC11Code>
<ProductNDC>54973-3316</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Oral Pain Relief</ProprietaryName>
<NonProprietaryName>Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum And Matricaria Chamomilla</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM</SubstanceName>
<StrengthNumber>12; 6; 30; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54973-3324-4</NDCCode>
<PackageDescription>6 g in 1 PACKET (54973-3324-4) </PackageDescription>
<NDC11Code>54973-3324-04</NDC11Code>
<ProductNDC>54973-3324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Nighttime Oral Pain Relief</ProprietaryName>
<NonProprietaryName>Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean And Oyster Shell Calcium Carbonate, Crude</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>HYLAND'S</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; SILICON DIOXIDE; ARNICA MONTANA; FERROSOFERRIC PHOSPHATE; ARABICA COFFEE BEAN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 30; 12; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170817</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3325-3</NDCCode>
<PackageDescription>6 g in 1 PACKET (54973-3325-3) </PackageDescription>
<NDC11Code>54973-3325-03</NDC11Code>
<ProductNDC>54973-3325</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Oral Pain Relief Nighttime</ProprietaryName>
<NonProprietaryName>Arnica Montana,tribasic Calcium Phosphate,silicon Dioxide,matricaria Chamomilla,ferrum Phosphoricum,arabica Coffee Bean,magnesium Phosphate, Dibasic Trihydrate And Oyster Shell Calcium Carbonate, Crude</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ARABICA COFFEE BEAN; FERRUM PHOSPHORICUM; SILICON DIOXIDE; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA</SubstanceName>
<StrengthNumber>12; 12; 6; 12; 12; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54973-3383-2</NDCCode>
<PackageDescription>6 TABLET in 1 PACKET (54973-3383-2) </PackageDescription>
<NDC11Code>54973-3383-02</NDC11Code>
<ProductNDC>54973-3383</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Leg Pain Relief</ProprietaryName>
<NonProprietaryName>Tribasic Calcium Phosphate, Arnica Montana, Oyster Shell Calcium Carbonate, Crude, Copper, Eupatorium Perfoliatum Flowering Top, Magnesium Phosphate, Dibasic Trihydrate, Phosphorus, Guaiacum Officinale Resin And Phosphoric Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COPPER; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; PHOSPHORUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORIC ACID</SubstanceName>
<StrengthNumber>12; 30; 12; 12; 30; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3391-1</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3391-1) > 29.6 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3391-01</NDC11Code>
<ProductNDC>54973-3391</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baby Oral Pain Relief Drops</ProprietaryName>
<NonProprietaryName>Ferrosoferric Phosphate,tribasic Calcium Phosphate,oyster Shell Calcium Carbonate,crude,arnica Montana,arabica Coffee Bean And Matricaria Chamomilla</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; ARABICA COFFEE BEAN; MATRICARIA CHAMOMILLA</SubstanceName>
<StrengthNumber>30; 12; 12; 12; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-2956-2</NDCCode>
<PackageDescription>2 CAPSULE in 1 BOTTLE (68071-2956-2) </PackageDescription>
<NDC11Code>68071-2956-02</NDC11Code>
<ProductNDC>68071-2956</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin</ProprietaryName>
<NonProprietaryName>Nitrofurantoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208516</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) and other antibacterial drugs,Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin Capsules , USP (monohydrate/macrocrystals)is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4- imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, Opacode ® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>54973-0229-1</NDCCode>
<PackageDescription>50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-0229-1) </PackageDescription>
<NDC11Code>54973-0229-01</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>19970717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>54973-0229-3</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (54973-0229-3) > 4 TABLET, SOLUBLE in 1 POUCH</PackageDescription>
<NDC11Code>54973-0229-03</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>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0232-1</NDCCode>
<PackageDescription>50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-0232-1) </PackageDescription>
<NDC11Code>54973-0232-01</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>N</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>54973-0232-3</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (54973-0232-3) / 4 TABLET, SOLUBLE in 1 POUCH</PackageDescription>
<NDC11Code>54973-0232-03</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>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0600-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0600-4) </PackageDescription>
<NDC11Code>54973-0600-04</NDC11Code>
<ProductNDC>54973-0600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aconite Napellis</ProprietaryName>
<NonProprietaryName>Aconitum Napellus Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ACONITUM NAPELLUS ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>