{
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
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"LastUpdate": "2020-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"NDC11Code": "55910-0205-12",
"ProductNDC": "55910-205",
"ProductTypeName": "HUMAN OTC DRUG",
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"StartMarketingDate": "20130411",
"EndMarketingDate": "20200411",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
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"ProductNdcExcludeFlag": "N",
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"PackageDescription": "1 TUBE in 1 CARTON (55910-061-64) / 28 g in 1 TUBE",
"NDC11Code": "55910-0061-64",
"ProductNDC": "55910-061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Antibiotic",
"NonProprietaryName": "Neomycin, Polymyxin B, Pramoxine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Dolgencorp Inc",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Triple Antibiotic",
"NonProprietaryName": "Bacitracin, Neomycin, Polymyxin B",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100207",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Dolgencorp Inc",
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"ProductNdcExcludeFlag": "N",
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{
"NDCCode": "55910-209-64",
"PackageDescription": "1 TUBE in 1 CARTON (55910-209-64) / 28 g in 1 TUBE",
"NDC11Code": "55910-0209-64",
"ProductNDC": "55910-209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Triple Antibiotic",
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"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150623",
"SamplePackage": "N",
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{
"NDCCode": "55910-225-64",
"PackageDescription": "1 TUBE in 1 CARTON (55910-225-64) / 28 g in 1 TUBE",
"NDC11Code": "55910-0225-64",
"ProductNDC": "55910-225",
"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "Maximum Strength Relief",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20100831",
"SamplePackage": "N",
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{
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"ApplicationNumber": "part338",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N"
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"RouteName": "ORAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
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"StrengthUnit": "mg/1",
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"LastUpdate": "2021-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20140201",
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"StartMarketingDatePackage": "20100130",
"SamplePackage": "N",
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{
"NDCCode": "55910-403-64",
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"NDC11Code": "55910-0403-64",
"ProductNDC": "55910-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20150123",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "OLD EAST MAIN CO.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
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"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150123",
"SamplePackage": "N",
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{
"NDCCode": "55910-446-64",
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"NDC11Code": "55910-0446-64",
"ProductNDC": "55910-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B, Pramoxine Hcl",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
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},
{
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"NDC11Code": "55910-0536-64",
"ProductNDC": "55910-536",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rexall Antibiotic",
"NonProprietaryName": "Bacitracin",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Dolgencorp, LLC",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
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},
{
"NDCCode": "55910-622-64",
"PackageDescription": "1 TUBE in 1 CARTON (55910-622-64) > 28 g in 1 TUBE",
"NDC11Code": "55910-0622-64",
"ProductNDC": "55910-622",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Anti Itch",
"NonProprietaryName": "Diphenhydramine Hydrochloride, Zinc Acetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Dolgencorp Inc",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE",
"StrengthNumber": "2; .1",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "55910-679-64",
"PackageDescription": "1 TUBE in 1 CARTON (55910-679-64) / 28 g in 1 TUBE",
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"ProductNDC": "55910-679",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Antibiotic",
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"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150926",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150926",
"SamplePackage": "N",
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},
{
"NDCCode": "55910-734-64",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (55910-734-64) > 64 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "55910-0734-64",
"ProductNDC": "55910-734",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181231",
"EndMarketingDate": "20241227",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181231",
"EndMarketingDatePackage": "20241227",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional sleeplessness."
},
{
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"NDC11Code": "55910-0860-64",
"ProductNDC": "55910-860",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"ProprietaryNameSuffix": "Nighttime",
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"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191227",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional sleeplessness."
},
{
"NDCCode": "55910-916-64",
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"ProductNDC": "55910-916",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191227",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191227",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional sleeplessness."
},
{
"NDCCode": "55910-973-64",
"PackageDescription": "1 TUBE in 1 CARTON (55910-973-64) > 28 g in 1 TUBE",
"NDC11Code": "55910-0973-64",
"ProductNDC": "55910-973",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rexall Hydrocortisone",
"ProprietaryNameSuffix": "Plus Moisturizers",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110114",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20110114",
"SamplePackage": "N"
},
{
"NDCCode": "0591-2132-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01) ",
"NDC11Code": "00591-2132-01",
"ProductNDC": "0591-2132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205811",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190621",
"SamplePackage": "N",
"IndicationAndUsage": "Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.",
"Description": "Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white to off white, biconvex film-coated, delayed-release tablets containing 10 mg of doxylamine succinate, USP and 10 mg of pyridoxine hydrochloride, USP. Tablets are printed with “2132” on one side with black ink and plain on the other. Inactive ingredients are as follows: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, magnesium stearate, magnesium trisilicate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, polysorbate 80, propylene glycol, talc, titanium dioxide. Doxylamine Succinate. Doxylamine succinate, USP is classified as an antihistamine. The chemical name for doxylamine succinate, USP is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The molecular formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate, USP is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride, USP is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride, USP is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The molecular formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride, USP is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "43353-205-05",
"PackageDescription": "4200 TABLET in 1 BOTTLE (43353-205-05)",
"NDC11Code": "43353-0205-05",
"ProductNDC": "43353-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090255",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2016-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160709",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE Hydrochloride Tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE Hydrochloride, USP. Tablets also contain microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid."
},
{
"NDCCode": "49884-186-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (49884-186-01) ",
"NDC11Code": "49884-0186-01",
"ProductNDC": "49884-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride, Delayed Release Tablets 10 Mg/10 Mg",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208518",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191219",
"SamplePackage": "N",
"IndicationAndUsage": "Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum.",
"Description": "Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are white, round, biconvex, film-coated, delayed-release tablet imprinted on one side with “186” in black color. Inactive ingredients are as follows: ammonium hydroxide, black iron oxide, colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer type C, microcrystalline cellulose, n-butanol, polyethylene glycol/macrogol, polysorbate 80, propylene glycol, shellac glaze, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white or almost white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white to practically white crystals or crystalline powder that is freely soluble in water, slightly soluble in alcohol and acetone, soluble in chloroform, insoluble in ether."
},
{
"NDCCode": "55494-100-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) ",
"NDC11Code": "55494-0100-10",
"ProductNDC": "55494-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclegis",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021876",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130515",
"SamplePackage": "N",
"IndicationAndUsage": "DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.",
"Description": "DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-100-99",
"PackageDescription": "12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) ",
"NDC11Code": "55494-0100-99",
"ProductNDC": "55494-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclegis",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021876",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "Y",
"IndicationAndUsage": "DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.",
"Description": "DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10) ",
"NDC11Code": "55494-0120-10",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "N",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60) ",
"NDC11Code": "55494-0120-60",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "N",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-94",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55494-0120-94",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250226",
"SamplePackage": "Y",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-99",
"PackageDescription": "6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) ",
"NDC11Code": "55494-0120-99",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "Y",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "63629-2184-1",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-2184-1) ",
"NDC11Code": "63629-2184-01",
"ProductNDC": "63629-2184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride, Delayed Release Tablets 10 Mg/10 Mg",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208518",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-05",
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"IndicationAndUsage": "Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum.",
"Description": "Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are white, round, biconvex, film-coated, delayed-release tablet imprinted on one side with “186” in black color. Inactive ingredients are as follows: ammonium hydroxide, black iron oxide, colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer type C, microcrystalline cellulose, n-butanol, polyethylene glycol/macrogol, polysorbate 80, propylene glycol, shellac glaze, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white or almost white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white to practically white crystals or crystalline powder that is freely soluble in water, slightly soluble in alcohol and acetone, soluble in chloroform, insoluble in ether."
},
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Azelastine Hydrochloride",
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"ProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
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"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
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"IndicationAndUsage": "Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.",
"Description": "Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
}
]
}
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<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>BACITRACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Synthesis & Repair [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
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<PackageDescription>1 TUBE in 1 CARTON (55910-622-64) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>55910-0622-64</NDC11Code>
<ProductNDC>55910-622</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dg Health Anti Itch</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride, Zinc Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Dolgencorp Inc</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE</SubstanceName>
<StrengthNumber>2; .1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>55910-679-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (55910-679-64) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>55910-0679-64</NDC11Code>
<ProductNDC>55910-679</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dg Health Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin, Neomycin, Polymyxin B, Pramoxine Hcl</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150926</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 3.5; 10000; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection and for temporary relief of pain or discomfort in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-734-64</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55910-734-64) > 64 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55910-0734-64</NDC11Code>
<ProductNDC>55910-734</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181231</StartMarketingDate>
<EndMarketingDate>20241227</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181231</StartMarketingDatePackage>
<EndMarketingDatePackage>20241227</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-860-64</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55910-860-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55910-0860-64</NDC11Code>
<ProductNDC>55910-860</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191227</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191227</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-916-64</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55910-916-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55910-0916-64</NDC11Code>
<ProductNDC>55910-916</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191227</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-973-64</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (55910-973-64) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>55910-0973-64</NDC11Code>
<ProductNDC>55910-973</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rexall Hydrocortisone</ProprietaryName>
<ProprietaryNameSuffix>Plus Moisturizers</ProprietaryNameSuffix>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-2132-01</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01) </PackageDescription>
<NDC11Code>00591-2132-01</NDC11Code>
<ProductNDC>0591-2132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205811</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white to off white, biconvex film-coated, delayed-release tablets containing 10 mg of doxylamine succinate, USP and 10 mg of pyridoxine hydrochloride, USP. Tablets are printed with “2132” on one side with black ink and plain on the other. Inactive ingredients are as follows: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, magnesium stearate, magnesium trisilicate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, polysorbate 80, propylene glycol, talc, titanium dioxide. Doxylamine Succinate. Doxylamine succinate, USP is classified as an antihistamine. The chemical name for doxylamine succinate, USP is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The molecular formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate, USP is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride, USP is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride, USP is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The molecular formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride, USP is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>43353-205-05</NDCCode>
<PackageDescription>4200 TABLET in 1 BOTTLE (43353-205-05)</PackageDescription>
<NDC11Code>43353-0205-05</NDC11Code>
<ProductNDC>43353-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090255</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2016-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE Hydrochloride Tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE Hydrochloride, USP. Tablets also contain microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>49884-186-01</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (49884-186-01) </PackageDescription>
<NDC11Code>49884-0186-01</NDC11Code>
<ProductNDC>49884-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride, Delayed Release Tablets 10 Mg/10 Mg</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208518</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are white, round, biconvex, film-coated, delayed-release tablet imprinted on one side with “186” in black color. Inactive ingredients are as follows: ammonium hydroxide, black iron oxide, colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer type C, microcrystalline cellulose, n-butanol, polyethylene glycol/macrogol, polysorbate 80, propylene glycol, shellac glaze, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white or almost white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white to practically white crystals or crystalline powder that is freely soluble in water, slightly soluble in alcohol and acetone, soluble in chloroform, insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-100-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) </PackageDescription>
<NDC11Code>55494-0100-10</NDC11Code>
<ProductNDC>55494-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclegis</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021876</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-100-99</NDCCode>
<PackageDescription>12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) </PackageDescription>
<NDC11Code>55494-0100-99</NDC11Code>
<ProductNDC>55494-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclegis</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021876</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140328</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
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<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
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<LastUpdate>2025-02-27</LastUpdate>
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<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
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<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
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<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
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<PackageDescription>1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
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<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250226</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
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<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride, Delayed Release Tablets 10 Mg/10 Mg</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208518</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg are white, round, biconvex, film-coated, delayed-release tablet imprinted on one side with “186” in black color. Inactive ingredients are as follows: ammonium hydroxide, black iron oxide, colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer type C, microcrystalline cellulose, n-butanol, polyethylene glycol/macrogol, polysorbate 80, propylene glycol, shellac glaze, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white or almost white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white to practically white crystals or crystalline powder that is freely soluble in water, slightly soluble in alcohol and acetone, soluble in chloroform, insoluble in ether.</Description>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (69168-479-64) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Azelastine Hydrochloride</ProprietaryName>
<NonProprietaryName>Azelastine Hydrochloride</NonProprietaryName>
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<ApplicationNumber>ANDA216421</ApplicationNumber>
<LabelerName>Allegiant Health</LabelerName>
<SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 nasal congestion, 2 runny nose, 3 runny nose, 4 itchy nose.</IndicationAndUsage>
</NDC>
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<ProductNDC>70505-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20181115</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021876</ApplicationNumber>
<LabelerName>Analog Pharma</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
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