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 6 of 44 · 880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WHITENING SUNSCREENANTI WRINKLE	WHITENING SUNSCREENANTI WRINKLE	Shantou Oushiya Biotechnology Co.,Ltd	524384e9-b3f8-4c13-e063-6394a90a8973	2026-05-20	Warnings	Exact identifier unii: 059QF0KO0R
REFRESH LACRI-LUBE	MINERAL OIL, PETROLATUM	Allergan, Inc.	d232a44b-516d-4cdf-a4e7-c3a9a50dc7af	2026-05-15	Warnings	Exact identifier unii: T5L8T28FGP
Scalpicin Anti-Itch Maximum Strength	HYDROCORTISONE	Reckitt Benckiser LLC	7b1a29fa-b266-43e6-a87b-aa3c96ab4041	2026-05-13	Warnings	Exact identifier unii: WI4X0X7BPJ
DERMFREE Anti-itch Cream	HYDROCORTISONE1% ANTI-ITCH CREAM	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	519c319a-9c43-0e63-e063-6394a90ab869	2026-05-13	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Systane Pro PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1	2026-05-12	Warnings	Exact identifier unii: 6DC9Q167V3
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	02ab1006-c7c8-42c9-bda8-62c9d7142521	2026-05-11	Adverse reactions	Exact identifier application number: ANDA088799 ndc (package): 68788-8583-2 ndc (product): 68788-8583 rxcui: 310891 spl id: 4dafae7f-7601-4812-a740-81935ae0d1f6 spl set id: 02ab1006-c7c8-42c9-bda8-62c9d7142521 unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	058bb2ff-ff51-4a3b-ba47-cb02272d0631	2026-05-11	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	12cd35e3-e707-4551-b778-bf615c1a8d32	2026-05-11	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
HYDROCORTISONE	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	0bbb8a63-ae1d-41d7-b201-d1b171b31f46	2026-05-11	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Preferred Pharmaceuticals, Inc.	026728d4-846b-4bd4-9183-ae6c4a714138	2026-05-11	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
Harris Teeter Hydrocortisone	HYDROCORTISONE	HARRIS TEETER LLC	4e8199f8-96ec-5342-e063-6294a90afb2d	2026-05-07	Warnings	Exact identifier unii: WI4X0X7BPJ
Sterile Water	WATER	Hospira, Inc.	3a6422e1-feee-4095-8883-2b0837039e6e	2026-05-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Chemstat	GLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,	Energique, Inc.	2831d28e-9cf1-4a72-9c6c-bb014d059558	2026-05-06	Warnings	Exact identifier unii: 8CRQ2TH63M
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc.	5114cdba-96a1-c399-e063-6294a90aac12	2026-05-06	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Multi Flower	AESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOS	Energique, Inc.	09c059e7-f748-402c-8447-af5b61169c58	2026-05-06	Warnings	Exact identifier unii: 059QF0KO0R
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	2026-04-29	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
anti itch	HYDROCORTISONE	HyVee Inc	e1db3641-2e83-4fec-8394-98d0d876ce0d	2026-04-29	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
FixMySkin Healing Balm Vanilla Flavor	HYDROCORTISONE	Lovely Skin, Inc.	52f7a561-a0b5-4562-a588-d74fd874b83a	2026-04-28	Warnings	Exact identifier unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	ef9cf62a-5805-48bc-915e-c0e91a10837e	2026-04-24	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	78f43570-b6fd-42eb-bb9e-580abf79bf0d	2026-04-24	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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