NDC 51672-3003-00 - Hydrocortisone

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: 51672-3003
Requested NDC: 51672-3003-00
Package NDCs from labels: 51672-3003-0, 51672-3003-2, 51672-3003-00
Manufacturer: Preferred Pharmaceuticals Inc.
Effective date: 2026-05-11
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Hydrocortisone Cream USP, 1% Cream USP, 2.5%	Preferred Pharmaceuticals Inc.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL
HYDROCORTISONE - DIRECT RX	DIRECT RX	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Cream USP, 1% Cream USP, 2.5%	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Cream USP, 1% Cream USP, 2.5%	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone - Aidarex Pharmaceuticals LLC	Aidarex Pharmaceuticals LLC	2014-01-04	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-3003-0	Hydrocortisone	1 in 1 CARTON	CREAM	1	8
51672-3003-0	Hydrocortisone	20 g in 1 TUBE	CREAM	20	8
51672-3003-2	Hydrocortisone	1 in 1 CARTON	CREAM	1	8
51672-3003-2	Hydrocortisone	28.35 g in 1 TUBE	CREAM	28.35	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-3003	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	5	Current NDC, Legacy NDC, 4 package rows	20231219_e4f22e9c-cf38-473a-8f7d-8da7fd696f76.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-3003-2	GM - Gram	51672-3003	56359cbc-d0e5-4fd6-b2c4-b483640c1033	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
isopropyl palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
lanolin alcohols	INACTIVE INGREDIENT	884C3FA9HE	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
sorbic acid	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [DIRECT RX]	1
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [DIRECT RX]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [DIRECT RX]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM [DIRECT RX]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HYDROCORTISONE CREAM [DIRECT RX]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [DIRECT RX]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [DIRECT RX]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE CREAM [DIRECT RX]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE CREAM [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [DIRECT RX]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [DIRECT RX]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE CREAM [DIRECT RX]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE CREAM [DIRECT RX]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [DIRECT RX]	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 34 of 44 · 880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itch and Rash Cream	HYDROCORTISONE	Wildman Business Group	1f95757d-a434-f02a-e063-6294a90a2d12	2024-09-01	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Multi-Phenolic	MANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,	Energique, Inc.	492b412a-01cc-48f2-bcdc-6fffcc651963	2024-08-23	Warnings	Exact identifier unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	84c95149-9064-4b4d-a7d0-93dfefca1370	2024-08-22	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
CVS Health Maximum Strength Scalp Relief Anti-itch	HYDROCORTISONE	CVS Health	b5ef0005-8b76-4205-8be0-db3a7ed7d1c4	2024-08-19	Warnings	Exact identifier unii: WI4X0X7BPJ
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Rite Aid Corporation	8e1f223a-a3a0-4837-9847-2a3939fcc595	2024-08-15	Warnings	Exact identifier unii: T5L8T28FGP
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	5bb279c6-d572-43a2-e053-2991aa0a686e	2024-08-14	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bryant Ranch Prepack	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2024-08-14	Warnings	Exact identifier unii: T5L8T28FGP
Osteoreg	ASAFOETIDA, KALI IODATUM, NATRUM SULPHURICUM, STILLINGIA SYLVATICA, ARANEA DIADEMA, VITAMIN D3, HYDROCORTISONE (CORTISOL), MERCURIUS PRAECIPITATUS RUBER, CALCAREA PHOSPHORICA, HEKLA LAVA, PARATHYROID GLAND (BOVINE), AURUM METALLICUM, LYCOPODIUM CLAVATUM, GAERTNER BACILLUS (BACH)	Deseret Biologicals, Inc.	f615d048-d794-4f16-b4c8-ceb8af2d236f	2024-08-14	Warnings	Exact identifier unii: WI4X0X7BPJ
Empathy	AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA	Deseret Biologicals, Inc.	a89067c1-ef12-49da-8fa6-e65ff664f497	2024-08-13	Warnings	Exact identifier unii: 059QF0KO0R
Hydrocortisone	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	fbbbcc67-b46d-d41a-e053-6294a90aa55d	2024-08-08	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	2024-08-07	Adverse reactions	Exact identifier unii: WI4X0X7BPJ
CVS Health Hydrocortisone Anti Itch	HYDROCORTISONE	CVS Health	546a1b8a-8254-432a-85c4-38ebee5ad568	2024-08-07	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	1cf056c4-01c6-424a-a436-779417eb8244	2024-08-06	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
CVS Health Maximum Strength Hydrocortisone	HYDROCORTISONE OINTMENT	CVS Health	ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3	2024-08-02	Warnings	Exact identifier unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	e1166b3a-a304-4030-ab51-eb55c6e91afd	2024-08-01	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	2dda4f32-e0f6-4e8d-8d75-10da5b762790	2024-07-22	Adverse reactions	Exact identifier unii: WI4X0X7BPJ
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	47bfae62-bf25-413e-93fc-3c72c901f1a5	2024-07-18	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	ac3947c9-5a66-b4e7-e053-2995a90a6f67	2024-07-17	Adverse reactions	Exact identifier application number: ANDA088799 ndc (package): 68071-2233-1 ndc (product): 68071-2233 rxcui: 310891 spl id: 1d763b7f-0758-7b27-e063-6294a90a422c spl set id: ac3947c9-5a66-b4e7-e053-2995a90a6f67 unii: WI4X0X7BPJ
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	6c676166-2471-478c-b662-f8c9c168977b	2024-07-17	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
HYDROCORTISONE	HYDROCORTISONE	Bryant Ranch Prepack	134fae59-f928-4304-86ca-2271b593caf4	2024-07-15	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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