Hydrocortisone

Product NDC: 67777-004
11-digit product format: 677770004
Labeler code: 67777
Product ID: 67777-004_0fa32e68-a566-6d7e-e063-6394a90af08b
Type: HUMAN OTC DRUG
Nonproprietary name: Antipruritic (Anti-Itch)
Dosage form: CREAM
Route: TOPICAL
Labeler: Dynarex Corporation
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-25
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
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
81dff9df-6f7e-49f0-e053-2a91aa0af7e7	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
67777-004-01	Hydrocortisone	72 in 1 CASE	CREAM	72	6
67777-004-02	Hydrocortisone	1 in 1 BOX	CREAM	1	6
67777-004-02	Hydrocortisone	28.4 g in 1 TUBE	CREAM	28.4	6
67777-004-03	Hydrocortisone	0.9 g in 1 PACKET	CREAM	0.9	6
67777-004-03	Hydrocortisone	144 in 1 BOX	CREAM	144	6
67777-004-04	Hydrocortisone	12 in 1 CASE	CREAM	12	6
67777-004-05	Hydrocortisone	600 in 1 CASE	CREAM	600	6
67777-004-06	Hydrocortisone	6 in 1 BOX	CREAM	6	6
67777-004-06	Hydrocortisone	0.9 g in 1 PACKET	CREAM	0.9	6
67777-004-07	Hydrocortisone	1800 in 1 CASE	CREAM	1800	6
67777-004-08	Hydrocortisone	25 in 1 BOX	CREAM	25	6
67777-004-08	Hydrocortisone	0.9 g in 1 PACKET	CREAM	0.9	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67777-004-01	GM - Gram	67777-004	6c247f91-33bb-4cd2-8f53-be407879b0d2	1	2023-07-06
67777-004-02	GM - Gram	67777-004	fe8b94f0-0824-49d0-9a3b-463ac914026c	1	2023-07-06
67777-004-03	EA - Each	67777-004	205cd319-7b85-423f-ba64-31687601096d	1	2023-07-06
67777-004-04	EA - Each	67777-004	5571e862-afb8-49c7-93e5-8c1205bc4a9b	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-004	HYDROCORTISONE (ANTIPRURITIC (ANTI-ITCH)) CREAM [DYNAREX CORPORATION]	6	Current NDC, Legacy NDC, 12 package rows	20240124_81dff9df-6f7e-49f0-e053-2a91aa0af7e7.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 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head and Shoulders Itchy Scalp	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	54df1acc-4265-494c-879e-c690184d7ae2	2026-03-13	Warnings	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	H E B	a58b9119-2adb-459f-86f4-95df28a430c5	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp Care	PYRITHIONE ZINC	Better Living Brands, LLC	f90d1fb2-4bd7-4d70-81b4-4541f4e3a3d6	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M032
Head and Shoulders Smooth and Silky Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	4cec08cb-aba5-41ce-e063-6294a90adfdf	2026-03-13	Warnings	Exact identifier application number: M032
OLIVITA Minoxidil	MINOXIDIL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	4cf37b0b-bbb8-1d9c-e063-6294a90af818	2026-03-13	Warnings	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Nice-Pak Products, LLC	3c55b70f-7627-8667-e063-6394a90a5cf8	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M032
Head and Shoulders 2in1 Classic Clean	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	65a4082f-227b-49bf-b88c-b1c651ed13a0	2026-03-12	Warnings	Exact identifier application number: M032
Head and Shoulders Green Apple 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	c036c9a6-6507-4037-b97b-1b015dd950c1	2026-03-12	Warnings	Exact identifier application number: M032
Anti-Fungal	ANTI-FUNGAL SHAMPOO	Shenzhen Mengyue Technology Co., Ltd.	4ca9a661-fa39-ab7f-e063-6294a90aed14	2026-03-10	Warnings	Exact identifier application number: M032
iBeaLee 5% Minoxidil Hair Regrowth Treatment	5% MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	4cb728d0-6abe-6645-e063-6394a90acb4c	2026-03-10	Warnings	Exact identifier application number: M032
DHS Tar	COAL TAR	Person and Covey	4c5f7278-c53a-cef6-e063-6394a90a0008	2026-03-09	Warnings	Exact identifier application number: M032
DHS ZINC	PYRITHIONE ZINC	Person and Covey	4c98c0af-c3d0-211e-e063-6294a90a8e12	2026-03-09	Warnings	Exact identifier application number: M032
DHS SAL	SALICYLIC ACID	Person and Covey	4c9b75b5-9c7d-c4a8-e063-6394a90a4a6b	2026-03-09	Warnings	Exact identifier application number: M032
DHS BODY WASH	ZINC PYRITHIONE WASH	Person and Covey	4c9d5b33-9a1e-9db1-e063-6294a90adbae	2026-03-09	Warnings	Exact identifier application number: M032
Biotin	BIOTIN	Shenzhen yuehaotong Technology Co.,Ltd	4c6ec616-a84e-6e1a-e063-6294a90a2aae	2026-03-07	Warnings	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	Old East Main Co.	5368b466-a804-471c-8287-0dd120c0d509	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M032
Dandruff	PYRITHIONE ZINC	Amazon.com Services LLC	c187bb79-8190-4a3d-a966-af74198ee546	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M032
Simply Clean Dandruff	PYRITHIONE ZINC	Old East Main Co.	643f571a-cf08-4f1f-9ad4-2bc68730ff57	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M032
Dry Scalp Care	PYRITHIONE ZINC	Old East Main Co.	3c433aa9-9451-4820-8b58-632cf6d0c92a	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	Old East Main Co.	3afc97ff-6a83-40af-9a61-26f00cfe4fa8	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M032

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	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	6
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	6
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	6
106258	hydrocortisone 1 % Topical Cream	SY	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	6
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67777-004-01	67777000401	72 BOX in 1 CASE (67777-004-01) / 1 TUBE in 1 BOX (67777-004-02) / 28.4 g in 1 TUBE	72 box	2021-03-25	0000-00-00	No	No	Current
67777-004-02	67777000402	1 in 1 BOX						Historical
67777-004-03	67777000403	0.9 g in 1 PACKET	0.9 g					Historical
67777-004-04	67777000404	12 BOX in 1 CASE (67777-004-04) / 144 PACKET in 1 BOX (67777-004-03) / .9 g in 1 PACKET	12 box	2021-03-25	0000-00-00	No	No	Current
67777-004-05	67777000405	600 BOX in 1 CASE (67777-004-05) / 6 PACKET in 1 BOX (67777-004-06) / .9 g in 1 PACKET	600 box	2021-03-25		No	No	Current
67777-004-06	67777000406	6 in 1 BOX						Historical
67777-004-07	67777000407	1800 BOX in 1 CASE (67777-004-07) / 25 PACKET in 1 BOX (67777-004-08) / .9 g in 1 PACKET	1800 box	2021-03-25		No	No	Current
67777-004-08	67777000408	25 in 1 BOX						Historical