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 39 of 44 · 880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
Petrocort Antipruritic Lip 21	HYDROCORTISONE	Clinical Formula LLC	7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b	2023-12-15	Warnings	Exact identifier unii: WI4X0X7BPJ
Humco Mineral Oil Heavy	MINERAL OIL	Humco Holding Group, Inc.	9f943fdf-5058-4e18-ba96-6be112bf72ca	2023-12-15	Warnings	Exact identifier unii: T5L8T28FGP
Humco Mineral Oil Light	MINERAL OIL	Humco Holding Group, Inc.	753f35c3-1420-4817-ba63-b737a9c99a1d	2023-12-15	Warnings	Exact identifier unii: T5L8T28FGP
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	db3a6c68-320b-46b0-83fa-6c29297a84a6	2023-12-15	Warnings	Exact identifier unii: 6DC9Q167V3
Systane	POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL	Alcon Research Ltd	14916d2c-a63d-491e-bd91-a61f300af38a	2023-12-15	Warnings	Exact identifier unii: 6DC9Q167V3
Systane Lubricant	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	15bc06ec-f3dc-3180-ca1a-106769a770ea	2023-12-15	Warnings	Exact identifier unii: 6DC9Q167V3
Systane ULTRA	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	2023-12-15	Warnings	Exact identifier unii: 6DC9Q167V3
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	7eaa93ca-c843-4c89-921b-c76659410dce	2023-12-14	Warnings	Exact identifier unii: 6DC9Q167V3
GenTeal Tears Gel Drops	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	84388a75-9d11-48ce-bf5a-88f0580d2d03	2023-12-14	Warnings	Exact identifier unii: 6DC9Q167V3
Hydrocortisone	HYDROCORTISONE 1%	Weeks & Leo Co., Inc.	0c5325e3-4796-856c-e063-6394a90a1f90	2023-12-12	Warnings	Exact identifier unii: WI4X0X7BPJ
Westlake Anti-itch	HYDROCORTISONE	Westlake Pharma LLC	0c53c982-3f23-a2d5-e063-6394a90acd55	2023-12-12	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Rite Aid Anti-itch	HYDROCORTISONE	Rite Aid	0c540422-1579-9217-e063-6294a90ad06a	2023-12-12	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Anti-itch Paraben Free	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c5419c5-0929-7ca6-e063-6294a90ac0a7	2023-12-12	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Rite Aid Hydrocortisone	HYDROCORTISONE 1%	Rite Aid	0c580f96-7fe9-19df-e063-6394a90a5a22	2023-12-12	Warnings	Exact identifier unii: WI4X0X7BPJ
Anti itch	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c58b750-d3a6-5ed1-e063-6294a90a4321	2023-12-12	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Mycozyl HC	TOLNAFTATE, HYDROCORTISONE	PURETEK CORPORATION	0c407982-192f-4c61-e063-6294a90a05d7	2023-12-11	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Altalube	MINERAL OIL AND PETROLATUM	Altaire Pharmaceuticals Inc.	eb65004c-c3a7-4079-bd75-f2857d30c68a	2023-12-09	Warnings	Exact identifier unii: T5L8T28FGP
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	2023-12-08	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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