NDC 51672-4146-01 - Phenytoin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 51672-4146
Requested NDC: 51672-4146-01
Package NDCs from labels: 51672-4146-6, 51672-4146-1, 51672-4146-3, 51672-4146-01
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-05-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Phenytoin - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - Major Pharmaceuticals	Major Pharmaceuticals	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL
Phenytoin	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.	2026-03-27	HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - NCS HealthCare of KY, LLC dba Vangard Labs	NCS HealthCare of KY, LLC dba Vangard Labs	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL
Phenytoin - American Health Packaging	American Health Packaging	2024-10-03	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-4146-1	Phenytoin	100 in 1 BOTTLE	TABLET, CHEWABLE	100	13
51672-4146-3	Phenytoin	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	13
51672-4146-6	Phenytoin	30 in 1 BOTTLE	TABLET, CHEWABLE	30	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4146	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	11	Current NDC, Legacy NDC, 3 package rows	20220702_78b38e7b-1460-4adc-b738-320ffa6259c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4146-1	EA - Each	51672-4146	cc471fd7-aa57-418d-af8a-92f796dded6c	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenytoin	ACTIVE INGREDIENT	6158TKW0C5	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Phenytoin	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Sucrose	INACTIVE INGREDIENT	C151H8M554	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]	5
Phenytoin	ACTIVE INGREDIENT	6158TKW0C5	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
Phenytoin	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
Saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 9 of 9 · 177 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CONSTIPATION CP	ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.	Natural Creations, Inc.	961b3ddf-41fe-46ed-b5e4-0fd8d9652edf	2021-11-15	Warnings	Exact identifier unii: LMI26O6933
ALUMINA	ALUMINA	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	f23b1f6d-d962-482b-9479-dcddf793aad3	2021-09-26	Warnings	Exact identifier unii: LMI26O6933
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	c67b3a39-ef78-5e81-e053-2a95a90a4786	2021-07-06	Warnings	Exact identifier unii: LMI26O6933
Alumina	ALUMINA	True Botanica, LLC	76b79bc7-55e0-4bdf-97c8-29022fcea01b	2021-01-30	Warnings	Exact identifier unii: LMI26O6933
Flora Plus	ALOE, ALUMINA, ANTIMON CRUD, ARG NIT, CHELIDONIUM MAJ, GAMBOGIA, GRAPHITES, HYDRASTIS, LYCOPODIUM, SILICEA	NET Remedies	fc1ced48-bd9f-4b3f-b786-573fba072975	2021-01-21	Warnings	Exact identifier unii: LMI26O6933
Metal	ALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIA	NET Remedies	f7682a4e-c767-4429-98aa-e8c5ef6560a6	2021-01-19	Warnings	Exact identifier unii: LMI26O6933
GUNA BOWEL PLUS	ACTIVATED CHARCOAL - ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - COLLINSONIA - FRANGULA ALNUS BARK - LYCOPODIUM CLAVATUM SPORE - POTASSIUM CARBONATE- RHUBARB - STRYCHNOS NUX VOMICA SEED - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - SUS SCROFA PANCREAS - TARAXACUM OFFICINALE - THIAMINE -	Guna spa	b3aa4fd3-c87a-ccd2-e053-2995a90a46a9	2021-01-17	Warnings	Exact identifier unii: LMI26O6933
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	997474d5-4dc4-6104-e053-2995a90a03f1	2020-12-07	Warnings	Exact identifier unii: LMI26O6933
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9a61f1ae-d3a4-68d7-e053-2a95a90a4333	2020-12-03	Warnings	Exact identifier unii: C151H8M554
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9aefc830-329c-5e35-e053-2a95a90a6ffe	2020-11-30	Warnings	Exact identifier unii: C151H8M554
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9af2d6f4-baa8-5da9-e053-2995a90a3dac	2020-11-30	Warnings	Exact identifier unii: C151H8M554
Constipation	ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM	Newton Laboratories, Inc.	90807700-3099-850c-e053-2995a90ada55	2020-11-24	Warnings	Exact identifier unii: LMI26O6933
Constipation	ABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUM	Newton Laboratories, Inc.	90804a94-1e67-3ab3-e053-2a95a90aafbe	2020-11-24	Warnings	Exact identifier unii: LMI26O6933
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	9042b7ad-15ed-0e81-e053-2a95a90afe28	2020-11-23	Warnings	Exact identifier unii: LMI26O6933
Post-Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	90bb15e5-3d9d-e2e2-e053-2995a90a85ac	2020-11-23	Warnings	Exact identifier unii: LMI26O6933
H.M.D.	ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM	Zorex International	8c53091a-904d-4756-93e4-17143c5b48e9	2018-12-21	Warnings	Exact identifier unii: LMI26O6933
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.