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 43 of 44 · 880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	459a9907-1261-4a75-8388-f0e2f466939c	2022-10-12	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	Asclemed USA, Inc.	eafad445-2735-434b-a1c6-e1c6b201d2cf	2022-09-07	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	f5ef71ae-fca9-4a57-ae88-f2b2d195a179	2022-08-01	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	d50240db-f630-4008-a272-55ba5c991304	2022-07-01	Adverse reactions	Exact identifier rxcui: 310891 unii: WI4X0X7BPJ
REFRESH P.M.	MINERAL OIL, PETROLATUM	Allergan, Inc.	24365d64-cd94-41cc-a7e1-033102d98114	2022-06-30	Warnings	Exact identifier unii: T5L8T28FGP
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Addiclenz	BETA VULGARIS, BOLDO, 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, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: Z8IX2SC1OH unii: A2I8C7HI9T
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	98042cef-2839-49d6-a7bd-a1d29c74430b	2022-05-02	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Proficient Rx LP	601cab21-c211-4c34-be7b-f4fdd97a921a	2022-05-02	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc	96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d	2021-08-31	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE	Sandoz Inc.	99d9030f-9118-412c-a377-d1df1c8fa723	2021-08-31	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	b8437441-a4a6-4fb5-82eb-e49af69704f4	2021-04-10	Warnings, Adverse reactions	Exact identifier unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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