Hydrocortisone

Product NDC: 61010-5800
Requested package NDC: 61010-5800-3
11-digit product format: 610105800
Labeler code: 61010
Product ID: 61010-5800_10d3fc91-82ae-e8eb-e063-6394a90ae87b
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-12-15
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	Warnings	Exact identifier application number: M017
Original Pain Relief	TOPICAL ANALGESIC LOTION	Real Time Pain Relief Inc	579bd303-9a50-4d66-e063-6294a90a6141	2026-07-27	Warnings	Exact identifier application number: M017
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Exact identifier application number: M017
RectoProtect	LIDOCAINE	Akron Pharma Inc.	1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb	2026-07-27	Warnings	Exact identifier application number: M017

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
da2b3b2c-11e0-401b-bbd2-d019271d1b3d	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-5800-2	2024-02-13	C162847	48780-1	1030e365-2764-111a-e063-dadaa90a10e2	61010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-3	2024-02-13	C162847	48780-1	1030e365-2764-111a-e063-dadaa90a10e2	61010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-4	2024-02-13	C162847	48780-1	1030e365-2764-111a-e063-dadaa90a10e2	61010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-2	2024-01-30	C162847	48780-1	1030e365-2764-111a-e063-dadaa90a10e2	61010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-3	2024-01-30	C162847	48780-1	1030e365-2764-111a-e063-dadaa90a10e2	61010-5800,Safetec First Aid 1% Hydrocortisone Cream
61010-5800-4	2024-01-30	C162847	48780-1	1030e365-2764-111a-e063-dadaa90a10e2	61010-5800,Safetec First Aid 1% Hydrocortisone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-5800-1	Hydrocortisone	0.9 g in 1 POUCH	CREAM	0.9	5
61010-5800-2	Hydrocortisone	144 in 1 BOX	CREAM	144	5
61010-5800-3	Hydrocortisone	25 in 1 BOX	CREAM	25	5
61010-5800-4	Hydrocortisone	10 in 1 BOX	CREAM	10	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
PEG-150 distearate	INACTIVE INGREDIENT	6F36Q0I0AC	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
steareth-20	INACTIVE INGREDIENT	L0Q8IK9E08	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-5800	HYDROCORTISONE CREAM [SAFETEC OF AMERICA, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20240214_da2b3b2c-11e0-401b-bbd2-d019271d1b3d.zip
61010-5800	CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC]	2	Current NDC, Legacy NDC	20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.zip

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	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	5
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	5
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	5
106258	hydrocortisone 1 % Topical Cream	SY	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	5
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	5
106258	hydrocortisone 1 % Topical Cream	PSN	fabcaa3b-d189-bd29-e053-6294a90ae86b	2
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	fabcaa3b-d189-bd29-e053-6294a90ae86b	2
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	fabcaa3b-d189-bd29-e053-6294a90ae86b	2
106258	hydrocortisone 1 % Topical Cream	SY	fabcaa3b-d189-bd29-e053-6294a90ae86b	2
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	fabcaa3b-d189-bd29-e053-6294a90ae86b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-5800-3	61010580003	25 POUCH in 1 BOX (61010-5800-3) / .9 g in 1 POUCH (61010-5800-1)	25 pouch	2010-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreens All-Purpose First Aid Kit 150 pieces	Walgreen Co.	2026-07-09	HUMAN OTC DRUG LABEL	1
Care Science All-Purpose First Aid Kit 300 pieces	ASO LLC	2026-07-08	HUMAN OTC DRUG LABEL	1
First Aid Only Hydrocortisone 1% Anti-Itch Cream	Acme United Corporation	2024-11-12	HUMAN OTC DRUG LABEL	2
61010-5800,Safetec First Aid 1% Hydrocortisone Cream	Safetec of America, Inc.	2024-02-07	HUMAN OTC DRUG LABEL	5
Care Science OSHA First Aid Kit	ASO LLC	2024-02-05	HUMAN OTC DRUG LABEL	2
Itch and Bite Relief First Aid Kit	WAL-MART STORES, INC.	2021-08-03	HUMAN OTC DRUG LABEL	3