Hydrocortisone 1%

Product NDC: 79503-103
11-digit product format: 795030103
Labeler code: 79503
Product ID: 79503-103_390f46a5-8f14-436b-ae32-960da9ee3737
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone Acetate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Ezricare Llc
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-08-19
Marketing end: 0000-00-00
Substance: HYDROCORTISONE ACETATE
Active strength: 10 mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	79503-103		D	Discontinued by firm		2026-10-05
excluded package	package	79503-103	79503-103-30	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79503-103-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79503-103-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
79503-103-30	GM - Gram	79503-103	c15c8ecb-81a7-4d96-8864-98a3826095aa	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79503-103	HYDROCORTISONE 1% (HYDROCORTISONE ACETATE) OINTMENT [EZRICARE LLC]	2	Legacy NDC	20240112_1ccb2b62-8dae-4840-bde6-e4b9ed764857.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79503-103-30	79503010330	1 TUBE in 1 CARTON (79503-103-30) > 30 g in 1 TUBE	1 tube	2021-08-19	0000-00-00	No	No	Current