Hydrocortisone

Product NDC: 47682-397
11-digit product format: 476820397
Labeler code: 47682
Product ID: 47682-397_3e4ef6bb-27cd-4a16-e063-6394a90a1e03
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Unifirst First Aid Corporation
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-04-15
Substance: HYDROCORTISONE
Active strength: 10 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47682-397	47682-397-12	D	Discontinued by firm		2026-10-20
excluded package	package	47682-397	47682-397-71	D	Discontinued by firm		2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	47682-397-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	47682-397-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	47682-397-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	47682-397-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	47682-397-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	47682-397-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	47682-397-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	47682-397-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	47682-397-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	47682-397-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	47682-397-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	47682-397-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	47682-397-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	47682-397-71	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	47682-397-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	47682-397-71	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	47682-397-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	47682-397-71	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	47682-397-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	47682-397-71	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	47682-397-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	47682-397-71	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	47682-397-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	47682-397-71	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	10 mg/g

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
69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	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
47682-397-12	Hydrocortisone	10 in 1 BOX	CREAM	10	14
47682-397-12	Hydrocortisone	0.9 g in 1 PACKET	CREAM	0.9	14
47682-397-35	Hydrocortisone	144 in 1 BAG	CREAM	144	14
47682-397-35	Hydrocortisone	0.9 g in 1 PACKET	CREAM	0.9	14
47682-397-71	Hydrocortisone	0.9 g in 1 PACKET	CREAM	0.9	14
47682-397-71	Hydrocortisone	20 in 1 BOX	CREAM	20	14
47682-397-73	Hydrocortisone	25 in 1 BOX	CREAM	25	14
47682-397-99	Hydrocortisone	0.9 g in 1 PACKET	CREAM	0.9	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3
white wax	INACTIVE INGREDIENT	7G1J5DA97F	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47682-397	HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]	13	Current NDC, Legacy NDC, 8 package rows	20240118_69d6645e-db3c-4dc0-a9a5-e2bc963e2f28.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 151 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOL BREEZE Pain Relief	MENTHOL	COOL BREEZE US LLC	14dcf4ee-6778-49d4-8601-9205737432ea	2023-11-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	1ebb45e5-4541-4c95-abe1-661ef763a610	2023-11-01	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Cream	LIDOCAINE 4%	Walgreens	ce1b55ed-f5c5-ea8b-e053-2a95a90acd40	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens pain relieving	LIDOCAINE 4%	Walgreens	ce2b9e57-749d-715c-e053-2995a90aaf8d	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens Cool n heat	LIDOCAINE 4% MENTHOL 1%	Walgreens	ce168ab7-ec4a-daea-e053-2995a90af829	2023-10-31	Warnings	Exact identifier application number: M017
Methyl Salicylate 40 Percent	METHYL SALICYLATE	Alexso, Inc	53407aab-094c-4393-a2b9-54fd85321e3e	2023-10-31	Warnings	Exact identifier application number: M017
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	Bentlin Products LLC	4346351c-8e11-46ae-b428-98d17f55beb9	2023-10-30	Warnings	Exact identifier application number: M017
Biofreeze Roll-On	MENTHOL	A-S Medication Solutions	814b37ea-5441-4cec-8794-71ca01d849ae	2023-10-30	Warnings	Exact identifier application number: M017
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Exact identifier application number: M017
Family Wellness	BENZOCAINE, RESORCINOL	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	df540eb8-6773-4647-9cc2-c3fd14d7355e	2023-10-27	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE 1%	FRONT PHARMACEUTICAL PLC	ea26265d-f24e-458e-8bf0-287b2d49f4f4	2023-10-27	Warnings	Exact identifier application number: M017
Joint Formula 88 MAX PLUS	CAMPHOR	Sarati International, Inc.	f5d78335-b78d-4909-a88b-9daa3c18ba15	2023-10-27	Warnings	Exact identifier application number: M017
OsmoFlex	MENTHOL	Sarati International, Inc.	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	2023-10-27	Warnings	Exact identifier application number: M017
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	FRONT PHARMACEUTICAL PLC	fde2069b-344e-46da-bb95-c5113e0f35d6	2023-10-26	Warnings	Exact identifier application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF	LIDOCAINE	CVS PHARMACY, INC	b61424bf-3b23-420b-a7bc-256ddb96aa22	2023-10-25	Warnings	Exact identifier application number: M017
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	b41091b4-0dc0-4a88-8ff6-11979b3d307a	2023-10-25	Warnings	Exact identifier application number: M017
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Exact identifier application number: M017
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	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	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	14
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	14
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	14
106258	hydrocortisone 1 % Topical Cream	SY	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	14
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47682-397-12	47682039712	10 in 1 BOX						Historical
47682-397-35	47682039735	144 PACKET in 1 BAG (47682-397-35) / .9 g in 1 PACKET	144 packet	2017-06-30	0000-00-00	No	No	Current
47682-397-71	47682039771	0.9 g in 1 PACKET	0.9 g					Historical
47682-397-73	47682039773	25 PACKET in 1 BOX (47682-397-73) / .9 g in 1 PACKET (47682-397-99)	25 packet	2016-06-06	0000-00-00	No	No	Current
47682-397-99	47682039799	0.9 g in 1 PACKET	0.9 g					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Green Guard Maximum Strength Hydrocortisone Cream 1%	Unifirst First Aid Corporation	2025-09-08	HUMAN OTC DRUG LABEL	14