hydrocortisone

Product NDC: 45802-276
11-digit product format: 458020276
Labeler code: 45802
Product ID: 45802-276_cf5167f6-cf70-463f-baf8-70fd83a993ff
Type: HUMAN OTC DRUG
Nonproprietary name: hydrocortisone
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-18
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
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
203105	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
0174411c-1b10-4298-b820-87b24065b118	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	Strength	SPL version
45802-276-03	hydrocortisone	1 in 1 CARTON	OINTMENT	1		7
45802-276-03	hydrocortisone	28 g in 1 TUBE	OINTMENT	28		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-276-03	GM - Gram	45802-276	abf87525-ae2d-49df-9e03-a92f2e815c44	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	3
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	3

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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Lidocaine Roll-on 2.5oz	LIDOCAINE	WellSpring Pharmaceutical Corporation	09b32a98-9131-451e-87a6-81a1e4ed7ec5	2023-04-25	Warnings	Exact identifier application number: M017
Icy Hot Pro Dry	CAMPHOR, MENTHOL	Chattem, Inc.	4de1bc29-d166-4599-9e75-5f841bf20967	2023-03-01	Warnings	Exact identifier application number: M017
Icy Hot Vanishing Scent	MENTHOL	Chattem, Inc.	e2092016-9741-433d-92e6-74bfddadb72c	2022-09-29	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Alexso, Inc	5dbd5fc0-a27e-4979-aca7-28f73096fd5f	2022-08-18	Warnings	Exact identifier application number: M017
FIRSTAR Sting Relief Pad	BENZOCAINE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	0e491a7a-4204-439f-862d-741cbc0be9fd	2021-07-06	Warnings	Exact identifier application number: M017
Arthritis Relief GoodSense	TROLAMINE SALICYLATE	Geiss, Destin & Dunn, Inc	a253730a-2187-07de-e053-2a95a90a9877	2020-04-02	Warnings	Exact identifier application number: M017
Aloe Cort	HYDROCORTISONE	Topiderm, Inc.	789a6669-3320-4558-8d6f-ab255db50d8d	2019-09-17	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	567b6820-fb52-630e-e063-6294a90a8bf8	2015-07-01	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	54e45d89-e8c3-6fc3-e063-6394a90aac4e	2015-06-15	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
203105	hydrocortisone 1 % Topical Ointment	PSN	0174411c-1b10-4298-b820-87b24065b118	7
203105	hydrocortisone 0.01 MG/MG Topical Ointment	SCD	0174411c-1b10-4298-b820-87b24065b118	7
203105	hydrocortisone 1 % Topical Ointment	SY	0174411c-1b10-4298-b820-87b24065b118	7
203105	hydrocortisone 1 % Topical Ointment	PSN	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	5
203105	hydrocortisone 0.01 MG/MG Topical Ointment	SCD	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	5
203105	hydrocortisone 1 % Topical Ointment	SY	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	5
203105	hydrocortisone 1 % Topical Ointment	PSN	99726aa3-3b45-4175-8471-279419af5457	3
203105	hydrocortisone 0.01 MG/MG Topical Ointment	SCD	99726aa3-3b45-4175-8471-279419af5457	3
203105	hydrocortisone 1 % Topical Ointment	SY	99726aa3-3b45-4175-8471-279419af5457	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-276-03	45802027603	1 TUBE in 1 CARTON (45802-276-03) / 28 g in 1 TUBE	1 tube	2011-08-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone 1% Drug Facts	Bryant Ranch Prepack	2026-03-18	HUMAN OTC DRUG LABEL	3
Hydrocortisone 1% Drug Facts	Padagis Israel Pharmaceuticals Ltd	2026-01-14	HUMAN OTC DRUG LABEL	7
Hydrocortisone 1% Drug Facts	A-S Medication Solutions	2024-10-02	HUMAN OTC DRUG LABEL	5