Hydrocortisone

Product NDC: 51672-2013
Requested package NDC: 51672-2013-3
11-digit product format: 516722013
Labeler code: 51672
Product ID: 51672-2013_390d1ba5-b204-ae55-e063-6294a90a77e3
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: 1995-08-23
Substance: HYDROCORTISONE
Active strength: 1 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
Brand name suffix: with Aloe
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	1 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
106258	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
caa2fd64-e262-4d7c-ad8a-69f506feba8c	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	SPL version
51672-2013-1	Hydrocortisonewith Aloe	14.2 g in 1 TUBE	CREAM	14.2	5
51672-2013-1	Hydrocortisonewith Aloe	1 in 1 CARTON	CREAM	1	5
51672-2013-2	Hydrocortisonewith Aloe	1 in 1 CARTON	CREAM	1	5
51672-2013-2	Hydrocortisonewith Aloe	28.4 g in 1 TUBE	CREAM	28.4	5
51672-2013-3	Hydrocortisonewith Aloe	60 g in 1 TUBE	CREAM	60	5
51672-2013-3	Hydrocortisonewith Aloe	1 in 1 CARTON	CREAM	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2013-1	GM - Gram	51672-2013	87032096-3d1b-41ba-b158-a04ffa9cd050	1	2013-03-03
51672-2013-2	GM - Gram	51672-2013	9666b4c8-273e-4737-8c31-b2126b89b2ce	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2013	HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [TARO PHAMACEUTICALS U.S.A., INC.]	4	Current NDC, Legacy NDC, 6 package rows	20241222_caa2fd64-e262-4d7c-ad8a-69f506feba8c.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 72 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buzz Away Sting Soothe	MENTHOL	Quantum, Inc.	419e34ea-17b2-ec32-e063-6394a90a603d	2025-10-20	Warnings	Exact identifier application number: M017
Family Care Anti-Itch	HYDROCORTISONE	United Exchange Corp.	deb09e89-9794-89a7-e053-2a95a90abdf8	2025-10-20	Warnings	Exact identifier application number: M017
Numbing Cream	MENTHOL	FlexiGo Inc	41571c8f-332b-f423-e063-6394a90a8897	2025-10-20	Warnings	Exact identifier application number: M017
Soothing Nerve Therapy	MENTHOL	Wise Consumer Products	40829d6b-5005-7ec9-e063-6294a90a970e	2025-10-20	Warnings	Exact identifier application number: M017
Numbing Cream	MENTHOL	FlexiGo Inc	4146fd51-b18c-393d-e063-6294a90a4d9a	2025-10-20	Warnings	Exact identifier application number: M017
Lidocaine 4% Maximum OTC Strength	LIDOCAINE	Cardinal Health 107, LLC	975031df-d46d-4098-b1c0-1c0c92b41995	2025-10-20	Warnings	Exact identifier application number: M017
Cortizone 10 Intensive Healing	HYDROCORTISONE	Chattem, Inc.	bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c	2025-10-20	Warnings	Exact identifier application number: M017
Sting relief pad	BENZOCAINE, ALCOHOL	Guangdong Comfort Medical Products Co., Ltd.	6e905065-10a9-1ded-e053-2a91aa0a46a1	2025-10-19	Warnings	Exact identifier application number: M017
CVS Cold and Hot	MENTHOL	CVS Pharmacy	a44cec95-822a-40b6-e053-2995a90ae31c	2025-10-17	Warnings	Exact identifier application number: M017
Sombra Max	SOMBRA MAX	Sombra Cosmetics Inc.	41623a46-e6e7-907e-e063-6394a90afc4c	2025-10-17	Warnings	Exact identifier application number: M017
POMADA DRAGON PAIN RELIEVING	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	TELEVISA CONSUMER PRODUCTS USA	c283291d-feaa-4f89-8fde-9e3957ea8b9f	2025-10-17	Warnings	Exact identifier application number: M017
Ear Pain MD	LIDOCAINE HYDROCHLORIDE	Eosera Inc	78c4418f-7f0f-447f-a94f-d4c89a081af1	2025-10-17	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	414217c1-ff3a-b556-e063-6394a90aa5db	2025-10-16	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	41422d04-160b-51b2-e063-6294a90ab2b2	2025-10-16	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	41427275-4c35-bbdf-e063-6294a90a14cf	2025-10-16	Warnings	Exact identifier application number: M017
Dollar General Menthol Pain Relief Gel Rollon	MENTHOL	Dolgencorp, LLC	3a9b99e2-36b8-5dcf-e063-6394a90a382d	2025-10-16	Warnings	Exact identifier application number: M017
Quality Choice	HYDROCORTISONE	Chain Drug Marketing Association, Inc.	24c3eb99-92ac-658c-e063-6394a90ab51f	2025-10-16	Warnings	Exact identifier application number: M017
DentiCalm	TOPICAL ANALGESIC	NFUSE LLC	414e6f6f-06bb-b470-e063-6294a90af390	2025-10-16	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	413008cd-d239-1453-e063-6394a90a74f2	2025-10-15	Warnings	Exact identifier application number: M017
PERFORM LEO EXTENSIVE PAIN RELIEF	LIDOCAINE, MENTHOL	PERFORM LEO LLC	f993ed5f-7dbb-4e3e-addf-f65b12f5cc48	2025-10-15	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
106258	hydrocortisone 1 % Topical Cream	PSN	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	5
106258	hydrocortisone 1 % Topical Cream	PSN	caa2fd64-e262-4d7c-ad8a-69f506feba8c	5
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	5
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	caa2fd64-e262-4d7c-ad8a-69f506feba8c	5
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	5
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	caa2fd64-e262-4d7c-ad8a-69f506feba8c	5
106258	hydrocortisone 1 % Topical Cream	SY	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	5
106258	hydrocortisone 1 % Topical Cream	SY	caa2fd64-e262-4d7c-ad8a-69f506feba8c	5
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	5
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	caa2fd64-e262-4d7c-ad8a-69f506feba8c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-2013-3	51672201303	1 TUBE in 1 CARTON (51672-2013-3) / 60 g in 1 TUBE	1 tube	2020-07-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone 1% with Aloe	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-03	HUMAN OTC DRUG LABEL	5
Hydrocortisone 1% with Aloe	Proficient Rx LP	2024-02-01	HUMAN OTC DRUG LABEL	5