Hydrocortisone

Product NDC: 51672-2013
Requested package NDC: 51672-2013-2
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 71 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Cold and Hot	MENTHOL, AND METHYL SALICYLATE	Safeway Inc.	ab201023-e3dc-52ec-e053-2995a90a1f18	2025-10-24	Warnings	Exact identifier application number: M017
HealthWise Medicated Cold Hot 5% Patch	MENTHOL	Veridian Healthcare	15aef56f-cd25-05ac-e063-6394a90a07bb	2025-10-23	Warnings	Exact identifier application number: M017
Alivio	LIDOCAINE	Amerise Pharmaceuticals LLC	eb3a98f1-c875-4f08-8b4b-44e22626b609	2025-10-23	Warnings	Exact identifier application number: M017
Pain Relieveing Gel-Patch	LIDOCAINE	Bullet point LLC	41d507c4-ad37-2686-e063-6394a90aae5b	2025-10-23	Warnings	Exact identifier application number: M017
ActivICE	MENTHOL	Medline Industries, LP	98fa9a34-0e1e-0997-e053-2a95a90ac77d	2025-10-23	Warnings	Exact identifier application number: M017
Coralite Pain Relief Hot	MENTHOL AND CAPSAICIN	United Exchange Corporation	78eb133d-01bb-6466-e053-2991aa0accc0	2025-10-23	Warnings	Exact identifier application number: M017
Americaine	BENZOCAINE	Insight Pharmaceuticals LLC	4fd14452-0285-40c4-b835-36935c2056b2	2025-10-23	Warnings	Exact identifier application number: M017
zourunan PAIN RELIEF	PAIN RELIEF	Guchutang Biotechnology (Longyan) Co., Ltd	41bc1c0c-63d5-0d41-e063-6394a90a341b	2025-10-22	Warnings	Exact identifier application number: M017
zourunan PAIN RELIEF	PAIN RELIEF	Guchutang Biotechnology (Longyan) Co., Ltd	41bd0769-6ba0-d0d5-e063-6294a90af7c9	2025-10-22	Warnings	Exact identifier application number: M017
Coralite Extra Strength Pain Relief Sleeve Knee	MENTHOL	United Exchange Corp.	aa5873bd-af64-41cc-8f16-7714c56bca96	2025-10-22	Warnings	Exact identifier application number: M017
Family Care Muscle Rub	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	United Exchange Corp.	63006bb5-76e8-eb64-e053-2991aa0a95ad	2025-10-22	Warnings	Exact identifier application number: M017
Winco Cold and Hot Medicated Patch Large	MENTHOL	WINCO FOODS, LLC	af0d86c4-f74e-2dbe-e053-2a95a90a74c1	2025-10-22	Warnings	Exact identifier application number: M017
Coralite Cold and Hot	MENTHOL	United Exchange Corp.	064a6149-a0e2-8a73-e063-6394a90a7953	2025-10-22	Warnings	Exact identifier application number: M017
Topical Analgesic	MENTHOL	Youngevity International Inc.	b4693947-f5b3-6fd3-e053-2995a90ab581	2025-10-22	Warnings	Exact identifier application number: M017
PAIN RELIEVING	LIDOCAINE	Medhome Pharma Inc	41cb1135-84e0-0c9a-e063-6294a90ada96	2025-10-22	Warnings	Exact identifier application number: M017
KINKAN	AMMONIA, CAMPHOR (NATURAL), MENTHOL	KINKANDO CO., LTD .	f2c0f3e1-792b-4798-bf6d-acd1bbefa261	2025-10-21	Warnings	Exact identifier application number: M017
Coralite Muscle and Joint Pain Relief	CAPSACIN	United Exchange Corp.	ba9a3d72-db7a-4dd0-9220-f43c9ed87114	2025-10-21	Warnings	Exact identifier application number: M017
Coralite Extra Strength Pain Relief Sleeve Wrist	MENTHOL	United Exchange Corp.	ae314478-b8ab-4e90-bd0a-7a882d5c1b2e	2025-10-21	Warnings	Exact identifier application number: M017
Coralite Cold and Hot	MENTHOL	United Exchange Corp.	85bd7658-e951-7daf-e053-2a91aa0a9f54	2025-10-21	Warnings	Exact identifier application number: M017
Family Care Maximum Strength Medicated Anti Itch	MENTHOL	United Exchange Corp.	430b5753-3087-4cb1-bf54-0eedc3f4b1d5	2025-10-21	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
51672-2013-2	51672201302	1 TUBE in 1 CARTON (51672-2013-2) / 28.4 g in 1 TUBE	1 tube	1995-08-23	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