Hydrocortisone 1%

Product NDC: 69396-050
11-digit product format: 693960050
Labeler code: 69396
Product ID: 69396-050_4c363aee-bd3b-680f-e063-6294a90a283b
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Trifecta Pharmaceuticals Usa Llc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-12-12
Substance: HYDROCORTISONE
Active strength: 1 g/100g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 1%
Listing expiration: 2027-12-31

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
9987165c-1a0f-dd57-e053-2a95a90ae735	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
69396-050-01	Hydrocortisone 1%	1 in 1 BOX	CREAM	1	7
69396-050-01	Hydrocortisone 1%	28.4 g in 1 TUBE	CREAM	28.4	7
69396-050-05	Hydrocortisone 1%	14.2 g in 1 TUBE	CREAM	14.2	7
69396-050-05	Hydrocortisone 1%	1 in 1 BOX	CREAM	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-050-01	GM - Gram	69396-050	4768efbf-5040-4e19-a2fd-94de01db1825	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-050	HYDROCORTISONE 1% (HYDROCORTISONE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]	6	Current NDC, Legacy NDC, 4 package rows	20250509_9987165c-1a0f-dd57-e053-2a95a90ae735.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 7 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Satogesic	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	cb000134-92a4-4304-8ef0-0347190e1414	2026-07-31	Warnings	Exact identifier application number: M017
Satogesic Hot	CAPSAICIN	Sato Pharmaceutical Co., Ltd.	16b47cb5-ea5f-4514-9a89-141ee4cc60f8	2026-07-31	Warnings	Exact identifier application number: M017
Satohap Cool and Hot Pads	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceutical Co., Ltd.	b6bf1eab-4ab9-f500-e053-2995a90a8d7b	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
SATOHAP COOL and HOT	CAMPHOR, CAPSAICIN, MENTHOL	Sato Pharmaceuticals Co., Ltd.	232a4c76-1a0c-2f4b-e063-6394a90a8849	2026-07-31	Warnings, Adverse reactions	Exact identifier application number: M017
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	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
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	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
Aspercreme Professional Cream	LIDOCAINE HCL 4%	Chattem, Inc.	ef297864-5917-4645-8ec7-f2bc49e037e8	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
HEMPE Ice Muscle and Joint Gel	MENTHOL	Healthcare International Research Limited	57aec922-1de4-c579-e063-6394a90af6c8	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

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	9987165c-1a0f-dd57-e053-2a95a90ae735	7
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	9987165c-1a0f-dd57-e053-2a95a90ae735	7
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	9987165c-1a0f-dd57-e053-2a95a90ae735	7
106258	hydrocortisone 1 % Topical Cream	SY	9987165c-1a0f-dd57-e053-2a95a90ae735	7
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	9987165c-1a0f-dd57-e053-2a95a90ae735	7
106258	hydrocortisone 1 % Topical Cream	PSN	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	1
106258	hydrocortisone 1 % Topical Cream	SY	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-050-01	69396005001	1 TUBE in 1 BOX (69396-050-01) / 28.4 g in 1 TUBE	1 tube	2019-12-12	0000-00-00	No	No	Current
69396-050-05	69396005005	1 TUBE in 1 BOX (69396-050-05) / 14.2 g in 1 TUBE	1 tube	2022-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Cream 1% ANTIPRURITIC (Anti-Itch) MAXIMUM STRENGTH	Preferred Pharmaceuticals Inc.	2026-04-22	HUMAN OTC DRUG LABEL	1
Hydrocortisone Cream 1% ANTIPRURITIC (Anti-Itch) MAXIMUM STRENGTH	Trifecta Pharmaceuticals Usa Llc	2026-03-04	HUMAN OTC DRUG LABEL	7