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 24 of 44 · 880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Proctosol-HC	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	565284e7-4994-486b-8267-18bd166655ac	2025-07-02	Adverse reactions	Exact identifier application number: ANDA088799 rxcui: 310891 unii: WI4X0X7BPJ
Cortizone 10 Water Resistant	HYDROCORTISONE	Chattem, Inc.	118e55e7-241f-44c4-959e-09bf6221bd77	2025-07-01	Warnings	Exact identifier unii: WI4X0X7BPJ
MediBalm	HYDROCORTISONE	BalmRx, LLC	324dd151-84c5-3e2f-e063-6394a90a569d	2025-06-26	Warnings	Exact identifier unii: WI4X0X7BPJ
Plaque identifying	PLAQUE IDENTIFYING	Shenzhen Yagao Technology Co., Ltd.	37eeb656-22f1-7372-e063-6394a90ad041	2025-06-19	Warnings	Exact identifier unii: 059QF0KO0R
Post-Treatment Repair Cream	HYDROCORTISONE	Vi Medical Products Inc.	ab8885a9-0778-28ff-e053-2995a90a2e12	2025-06-19	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37cdfabc-1fdb-246a-e063-6394a90a008a	2025-06-17	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37ce6c35-b211-43de-e063-6294a90ab773	2025-06-17	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	Sun Pharmaceutical Industries, Inc.	312ddc8d-100e-cfac-e063-6294a90acd09	2025-06-16	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
ProCure Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Twin Med LLC	37a4cc43-0d53-f1bf-e063-6394a90a2dc9	2025-06-15	Warnings	Exact identifier unii: T5L8T28FGP
Hemorrhoidal Pain Relief	HEMORRHOIDAL PAIN RELIEF OINTMENT	Neilmed Pharmaceuticals Inc.	374d89b6-9305-9adf-e063-6394a90adb32	2025-06-11	Warnings	Exact identifier unii: T5L8T28FGP
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	4eb3c9ac-268a-5246-e054-00144ff88e88	2025-06-09	Warnings	Exact identifier unii: T5L8T28FGP
Sterile Water	WATER	Henry Schein, Inc.	88403fcf-a276-42c0-88b6-bd84a720b564	2025-05-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	f7aecfb4-c194-4554-8d05-4e46005e654b	2025-05-27	Warnings	Exact identifier unii: WI4X0X7BPJ
Seacall Hydrocortisone Ointment.	SEACALL HYDROCORTISONE OINTMENT	Guangdong Quadrant Ecological Technology Co., Ltd.	3616980a-03dc-deba-e063-6394a90a6ce7	2025-05-26	Warnings	Exact identifier unii: WI4X0X7BPJ
Mineral Oil	MINERAL OIL	ATLANTIC BIOLOGICALS CORP.	960502ae-2468-406e-8799-cacb01f2727e	2025-05-23	Warnings	Exact identifier unii: T5L8T28FGP
Insecticides/Pest/Food Additives Detox	BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Dr. Donna Restivo DC	b5778211-0e3e-44ef-bd65-a76a68cf1504	2025-05-23	Warnings	Exact identifier unii: Z8IX2SC1OH unii: A2I8C7HI9T
Eyesaline Emergency Eyewash	STERILE EYESALINE EYEWASH	Honeywell Safety Products USA, Inc.	2d567518-4c54-7448-e063-6294a90a3e64	2025-05-14	Warnings	Exact identifier unii: 059QF0KO0R
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	d57a59fb-c8f2-f73b-e053-2995a90a4cdb	2025-05-08	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	4c96ec41-841c-322b-e054-00144ff8d46c	2025-05-08	Warnings	Exact identifier rxcui: 106258 unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	0d7e8e04-9149-4436-bad1-b700e253b7ab	2025-05-05	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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