hydrocortisone

Product NDC: 45802-438
Requested package NDC: 45802-438-05
11-digit product format: 458020438
Labeler code: 45802
Product ID: 45802-438_adca01b2-b9fa-4785-be0e-1bd493446cc7
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-05-06
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45802-438	45802-438-05	D	Discontinued by firm		2026-10-16

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: 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
2dc7f76f-f9ad-46ba-8b41-952e1c15f052	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
45802-438-03	hydrocortisone	28 g in 1 TUBE	CREAM	28	9
45802-438-03	hydrocortisone	1 in 1 CARTON	CREAM	1	9
45802-438-05	hydrocortisone	454 g in 1 JAR	CREAM	454	9
45802-438-70	hydrocortisone	144 in 1 CARTON	CREAM	144	9
45802-438-70	hydrocortisone	.9 g in 1 PACKET	CREAM	.9	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-438-03	GM - Gram	45802-438	3634198b-3abd-46dd-9e1a-f43c8f37ad45	1	2012-07-24
45802-438-05	GM - Gram	45802-438	e7af108f-440a-4ff7-94c2-15cb34cf5cea	1	2012-07-24
45802-438-70	EA - Each	45802-438	3d62d85d-e8af-4abb-8dee-b614f448fd9e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [PERRIGO NEW YORK INC]	2
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-438	HYDROCORTISONE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]	8	Current NDC, Legacy NDC, 5 package rows	20241011_2dc7f76f-f9ad-46ba-8b41-952e1c15f052.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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REINREUDE BACK PAIN THERAPY	CAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPY	Jiangxi Yudexi Pharmaceutical Co., LTD	4dfc77bb-11dd-e0f0-e063-6294a90a4e9c	2026-07-24	Warnings	Exact identifier application number: M017
DRAVYNOR QUIT SMOKING Patches	NICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHES	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5768631f-d517-5b43-e063-6294a90a8f46	2026-07-24	Warnings	Exact identifier application number: M017
DERMFREE NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5b47ce-2bf1-42c7-e063-6294a90af09f	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE WART CORN REMOVER	SALICYLIC ACID 40% WART CORN REMOVER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c63b3-44de-8736-e063-6394a90ac21a	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE Anti-itch	HYDROCORTISONE1% ANTI-ITCH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5af4c6-555a-e74c-e063-6394a90aa6ce	2026-07-23	Warnings	Exact identifier application number: M017
DERMFREE HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5d0e79-d620-0147-e063-6294a90a3103	2026-07-23	Warnings	Exact identifier application number: M017
MAG 5 PT WARMING FORMULA	MENTHOL	RENU LABORATORIES, LLC	a499ac9b-0e8e-e23f-e053-2a95a90abe9a	2026-07-23	Warnings	Exact identifier application number: M017
Icy Hot Performance Cream Pain Relief	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	73f7a113-ef11-4932-bf4d-4e62863f7941	2026-07-23	Warnings	Exact identifier application number: M017
Numbing Pain Relief	LIDOCAINE 4%	Walgreen Company	2425badb-e196-e9f8-e063-6294a90a7bf4	2026-07-22	Warnings	Exact identifier application number: M017
Cooling Pain Relief	MENTHOL 4.5%	Walgreen Company	24345ccf-c96f-31b0-e063-6294a90a82b5	2026-07-22	Warnings	Exact identifier application number: M017
Heat Pain Relief	CAPSAICIN 0.1%	Walgreen Company	2434f9cf-74aa-17af-e063-6294a90a56d9	2026-07-22	Warnings	Exact identifier application number: M017
Pain Relief Patch Lidocaine	LIDOCAINE	HyVee	41c26a66-3371-2c2c-e063-6294a90aa38b	2026-07-22	Warnings	Exact identifier application number: M017
CVS Ultra Strength Muscle	MENTHOL, CAMPHOR, METHYL SALICYLATE	CVS Pharmacy	48bef8bc-6e39-a328-e063-6394a90ae450	2026-07-22	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	AKRON PHARMA INC	daad9a1e-98d2-4ce7-9d97-ac5d81905abb	2026-07-22	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative	573c2d85-9e0b-7955-e063-6394a90aff64	2026-07-22	Warnings	Exact identifier application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF	BENZALKONIUM CHLORIDE, LIDOCAINE	Enviro Specialty Chemicals Inc	f7abe66c-dc2d-4ef7-9b11-5b87157fd302	2026-07-21	Warnings	Exact identifier application number: M017
Bclsks NUMBING	MENTHOL 1% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	49e26770-ddf6-7515-e063-6394a90a4ab3	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE21MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5e9691-727f-6bcd-e063-6294a90aadfc	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE14MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5eec19-7f9a-d277-e063-6294a90ace95	2026-07-21	Warnings	Exact identifier application number: M017
Rstrvbr QUIT SMOKING	NICOTINE7MG QUIT SMOKING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5f124e-2dd7-16b8-e063-6294a90a5cdb	2026-07-21	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	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	9
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	9
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	9
106258	hydrocortisone 1 % Topical Cream	SY	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	9
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	9
106258	hydrocortisone 1 % Topical Cream	PSN	12cd35e3-e707-4551-b778-bf615c1a8d32	6
106258	hydrocortisone 1 % Topical Cream	PSN	a0fde5c9-afb2-76a9-e053-2995a90af3e8	6
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	12cd35e3-e707-4551-b778-bf615c1a8d32	6
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	a0fde5c9-afb2-76a9-e053-2995a90af3e8	6
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	a0fde5c9-afb2-76a9-e053-2995a90af3e8	6
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	12cd35e3-e707-4551-b778-bf615c1a8d32	6
106258	hydrocortisone 1 % Topical Cream	SY	a0fde5c9-afb2-76a9-e053-2995a90af3e8	6
106258	hydrocortisone 1 % Topical Cream	SY	12cd35e3-e707-4551-b778-bf615c1a8d32	6
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	a0fde5c9-afb2-76a9-e053-2995a90af3e8	6
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	12cd35e3-e707-4551-b778-bf615c1a8d32	6
106258	hydrocortisone 1 % Topical Cream	PSN	b6734f71-dcbc-49ac-9c13-455ed624d08f	5
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	b6734f71-dcbc-49ac-9c13-455ed624d08f	5
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	b6734f71-dcbc-49ac-9c13-455ed624d08f	5
106258	hydrocortisone 1 % Topical Cream	SY	b6734f71-dcbc-49ac-9c13-455ed624d08f	5
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	b6734f71-dcbc-49ac-9c13-455ed624d08f	5
106258	hydrocortisone 1 % Topical Cream	PSN	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	3
106258	hydrocortisone 1 % Topical Cream	PSN	47e9fe84-bd0c-40ea-85de-e950bcacc557	3
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	3
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	47e9fe84-bd0c-40ea-85de-e950bcacc557	3
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	47e9fe84-bd0c-40ea-85de-e950bcacc557	3
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	3
106258	hydrocortisone 1 % Topical Cream	SY	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	3
106258	hydrocortisone 1 % Topical Cream	SY	47e9fe84-bd0c-40ea-85de-e950bcacc557	3
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	484fe5e4-a058-49c0-a382-c8fc3e20c3b2	3
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	47e9fe84-bd0c-40ea-85de-e950bcacc557	3
106258	hydrocortisone 1 % Topical Cream	PSN	96a2d2c6-cc01-4df3-a572-fff39334d91e	1
106258	hydrocortisone 1 % Topical Cream	PSN	9c0feade-bb3f-4251-b8ae-aee4f548238f	1
106258	hydrocortisone 1 % Topical Cream	PSN	20b3934b-edc4-40b8-b5fa-17259a200c5d	1
106258	hydrocortisone 1 % Topical Cream	PSN	ee64ad1e-78db-4553-a3cf-b539b770fa26	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	96a2d2c6-cc01-4df3-a572-fff39334d91e	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	9c0feade-bb3f-4251-b8ae-aee4f548238f	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	ee64ad1e-78db-4553-a3cf-b539b770fa26	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	20b3934b-edc4-40b8-b5fa-17259a200c5d	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	96a2d2c6-cc01-4df3-a572-fff39334d91e	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	ee64ad1e-78db-4553-a3cf-b539b770fa26	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	9c0feade-bb3f-4251-b8ae-aee4f548238f	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	20b3934b-edc4-40b8-b5fa-17259a200c5d	1
106258	hydrocortisone 1 % Topical Cream	SY	9c0feade-bb3f-4251-b8ae-aee4f548238f	1
106258	hydrocortisone 1 % Topical Cream	SY	96a2d2c6-cc01-4df3-a572-fff39334d91e	1
106258	hydrocortisone 1 % Topical Cream	SY	20b3934b-edc4-40b8-b5fa-17259a200c5d	1
106258	hydrocortisone 1 % Topical Cream	SY	ee64ad1e-78db-4553-a3cf-b539b770fa26	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	9c0feade-bb3f-4251-b8ae-aee4f548238f	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	96a2d2c6-cc01-4df3-a572-fff39334d91e	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	ee64ad1e-78db-4553-a3cf-b539b770fa26	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	20b3934b-edc4-40b8-b5fa-17259a200c5d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-438-05	45802043805	1 JAR in 1 CARTON (45802-438-05) > 454 g in 1 JAR	1 jar	2011-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Cream 1% Drug Facts	A-S Medication Solutions	2026-09-16	HUMAN OTC DRUG LABEL	7
Hydrocortisone Cream 1% Drug Facts	Bryant Ranch Prepack	2026-08-04	HUMAN OTC DRUG LABEL	4
Perrigo Hydrocortisone Cream 1% Drug Facts	Preferred Pharmaceuticals Inc.	2026-05-11	HUMAN OTC DRUG LABEL	6
Hydrocortisone Cream 1% Drug Facts	Padagis Israel Pharmaceuticals Ltd	2026-04-29	HUMAN OTC DRUG LABEL	9
Hydrocortisone Cream 1%Drug Facts	Sportpharm LLC	2026-02-06	HUMAN OTC DRUG LABEL	1
Perrigo Hydrocortisone Cream 1% Drug Facts	NuCare Pharmaceuticals,Inc.	2025-07-21	HUMAN OTC DRUG LABEL	6
Hydrocortisone Cream 1% Drug Facts	Proficient Rx LP	2024-02-01	HUMAN OTC DRUG LABEL	3
Perrigo Hydrocortisone Cream 1% Drug Facts	A-S Medication Solutions	2021-03-01	HUMAN OTC DRUG LABEL	1
Perrigo Hydrocortisone Cream 1% Drug Facts	Central Texas Community Health Centers	2017-08-28	HUMAN OTC DRUG LABEL	1
Perrigo Hydrocortisone Cream 1% Drug Facts	Rebel Distributors Corp	2012-03-06	HUMAN OTC DRUG LABEL	1