HYDROCORTISONE

Product NDC: 0498-0801
Requested package NDC: 0498-0801-33
11-digit product format: 004980801
Labeler code: 0498
Product ID: 0498-0801_f0eccc8a-2ea4-063e-e053-2a95a90a18f7
Type: HUMAN OTC DRUG
Nonproprietary name: Anti-itch
Dosage form: CREAM
Route: TOPICAL
Labeler: Honeywell Safety Products USA, inc
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-10-15
Marketing end: 0000-00-00
Substance: HYDROCORTISONE ACETATE
Active strength: 1 g/100g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0498-0801	0498-0801-33	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
0498-0801-33	00498080133	100 PACKET in 1 BOX, UNIT-DOSE (0498-0801-33) > .9 g in 1 PACKET	100 packet	2019-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0498-4223, 4275: First Aid Kit (FABC, HC cr, BZK wipes- 34575H, SF00001582)	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	8
0498-4274: First Aid Kit (Triple, FABC, HC cr, BZK wipes- SF00001563)	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	8
4149 First Aid Kit	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	8
4318 First Aid Kit	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	8
0498-4219: First Aid Kit (EW, triple, HC cr, Sting relief- 013061-4454)	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	7
4391 First Aid Kit	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	7
gel for burns	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	7
4383 First Aid Kit	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	7
4349 First Aid Kit	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	7
4298 First Aid Kit	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	7
gel for burns	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	7
0498-4348: First Aid Kit (HC cr, PVP wipes, sting relief- 013058-4344)	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	7
4357 First Aid Kit	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	7
0498-0801: 1% Hydrocortisone Cream	Honeywell Safety Products USA, inc	2024-01-22	HUMAN OTC DRUG LABEL	6
4360 First Aid Kit	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	6
4365 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-29	HUMAN OTC DRUG LABEL	4
gel for burns	Honeywell Safety Products USA, Inc.	2021-12-26	HUMAN OTC DRUG LABEL	4
4286 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-24	HUMAN OTC DRUG LABEL	4
4382 First Aid Kit	Honeywell Safety Products USA, Inc.	2021-12-23	HUMAN OTC DRUG LABEL	7
4248 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-23	HUMAN OTC DRUG LABEL	5
4129 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-23	HUMAN OTC DRUG LABEL	4
4246 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-23	HUMAN OTC DRUG LABEL	4
4362 First Aid Kit	Honeywell Safety Products USA, Inc.	2021-12-23	HUMAN OTC DRUG LABEL	3

HYDROCORTISONE

NDC auxiliary status#

Observed NDC auxiliary status history#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#