Hydrocortisone

Product NDC: 51672-2010
11-digit product format: 516722010
Labeler code: 51672
Product ID: 51672-2010_390d0eb8-c4dc-e391-e063-6394a90a7333
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2001-09-13
Substance: HYDROCORTISONE
Active strength: .5 g/100g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocortisone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198707	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2ada9ec2-1c28-4da2-8639-07b3193ffb32	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-2010-2	Hydrocortisone	1 in 1 CARTON	CREAM	1		4
51672-2010-2	Hydrocortisone	28.4 g in 1 TUBE	CREAM	28.4		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2010-2	GM - Gram	51672-2010	31d0c650-6ea3-41fe-a826-c485829d79ee	1	2013-03-03

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.]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sodium cetostearyl sulfate	INACTIVE INGREDIENT	7ZBS06BH4B	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2010	HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 2 package rows	20241222_2ada9ec2-1c28-4da2-8639-07b3193ffb32.zip

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 36 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numbsure LIDOCAINE	LIDOCAINE 4%	Hambli Limited	43a65a12-ef2a-4608-e063-6394a90a82ea	2026-01-31	Warnings	Exact identifier application number: M017
Collajoint Lidocaine Pain Relief Gel Patch	LIDOCAINE PAIN RELIEF GEL PATCH	Henan Enokon Medical Instrument Co., Ltd.	44e27e7f-992f-d194-e063-6294a90a94e4	2026-01-31	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT Patch	CAPSAICIN HEAT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac2045-2c07-af9a-e063-6294a90a052a	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac6a7b-25d3-6dc4-e063-6394a90a99b6	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49aca763-be2a-cf38-e063-6294a90a092e	2026-01-31	Warnings	Exact identifier application number: M017
PAIN RELIEF HOT Patch	PAIN RELIEF HOT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ad128a-0f4c-085a-e063-6294a90ac9bb	2026-01-31	Warnings	Exact identifier application number: M017
Walgreens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	3557d2e9-714a-4066-aa73-ea9e3363e574	2026-01-30	Warnings	Exact identifier application number: M017
Alveora HEMORRHOID MASTER	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	4996f96a-898e-de01-e063-6394a90a3907	2026-01-30	Warnings	Exact identifier application number: M017
Sunburn Relief	LIDOCAINE HCL 0.5%	Rite Aid Corporation	b67af0c7-1ae8-4494-bb0e-d7f66ebca352	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS	CAPSAICIN	OL PHARMA TECH,LLC	48fdf9dc-05df-866d-e063-6294a90ae03a	2026-01-30	Warnings	Exact identifier application number: M017
ROCKTAPE GO Kinesiology Tape and Analgesic	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	b779c7d8-dbe6-472f-9282-6cced25cfd2e	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	de5f7add-1f2b-438a-ac17-753ebb53e697	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll-On	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	5a2d9c3a-67fc-4c1a-b1e8-62a93880397a	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Dr. Collado	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A	c0dad2db-7c96-49b8-a451-bf8cfa7f798b	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	3121c7f7-d7e5-4ca9-9057-03edf9c94c56	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A.	87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d	2026-01-29	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone Cream Plus	HYDROCORTISONE	Rooftop Consumer Health, Inc.	fe334cae-e019-4397-8498-df3c923ae8b5	2026-01-29	Warnings	Exact identifier application number: M017
Red Oil Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL, PHENOL	The Red Oil Company Inc	1e36579a-72da-46ba-ac72-5960a11c0880	2026-01-29	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM, MENTHOL	NATURES FORMULAE HEALTH PRODUCTS LTD.	498a5e2a-4de0-561c-e063-6394a90ac05c	2026-01-29	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET POTENT PAIN RELIEF	45c76956-db3f-3e84-e063-6394a90adce1	2026-01-29	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198707	hydrocortisone 0.5 % Topical Cream	PSN	2ada9ec2-1c28-4da2-8639-07b3193ffb32	4
198707	hydrocortisone 0.5 % Topical Cream	PSN	ccb62898-b614-45b9-95ea-23e5e31893a8	4
198707	hydrocortisone 5 MG/ML Topical Cream	SCD	2ada9ec2-1c28-4da2-8639-07b3193ffb32	4
198707	hydrocortisone 5 MG/ML Topical Cream	SCD	ccb62898-b614-45b9-95ea-23e5e31893a8	4
198707	hydrocortisone 0.5 % Topical Cream	SY	2ada9ec2-1c28-4da2-8639-07b3193ffb32	4
198707	hydrocortisone 0.5 % Topical Cream	SY	ccb62898-b614-45b9-95ea-23e5e31893a8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2010-2	51672201002	1 TUBE in 1 CARTON (51672-2010-2) / 28.4 g in 1 TUBE	1 tube	2001-09-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone ½%	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-03	HUMAN OTC DRUG LABEL	4
Hydrocortisone ½%	Proficient Rx LP	2024-02-01	HUMAN OTC DRUG LABEL	4