Zinc Oxide

Product NDC: 61554-100
11-digit product format: 615540100
Labeler code: 61554
Product ID: 61554-100_9b7f447d-bdef-7034-e053-2995a90a92ac
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide Ointment
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Gentell, Inc.
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-11-03
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 0 g/g
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61554-100		I	Inactivated by FDA	2026-10-05
excluded package	package	61554-100	61554-100-01	I	Inactivated by FDA	2026-10-05
excluded package	package	61554-100	61554-100-02	I	Inactivated by FDA	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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61554-100-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61554-100-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61554-100-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61554-100-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61554-100-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61554-100-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61554-100-01	2025-07-29	C162847	48780-1	3b156c62-2e31-fb37-e063-e6dba90a4e07	Zinc Oxide Ointment
61554-100-02	2025-07-29	C162847	48780-1	3b156c62-2e31-fb37-e063-e6dba90a4e07	Zinc Oxide Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61554-100-01	Zinc Oxide	28.3 g in 1 TUBE	OINTMENT	28.3		4
61554-100-02	Zinc Oxide	453.6 g in 1 JAR	OINTMENT	453.6		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61554-100	ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [GENTELL, INC.]	4	Legacy NDC, 2 package rows	20240809_5f8a8927-970c-1e0a-e053-2a91aa0a6f43.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	5f8a8927-970c-1e0a-e053-2a91aa0a6f43	4
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	5f8a8927-970c-1e0a-e053-2a91aa0a6f43	4
198911	zinc oxide 20 % Topical Ointment	SY	5f8a8927-970c-1e0a-e053-2a91aa0a6f43	4
198911	zinc oxide 200 MG per GM Topical Ointment	SY	5f8a8927-970c-1e0a-e053-2a91aa0a6f43	4
198911	ZNO 0.2 MG/MG Topical Ointment	SY	5f8a8927-970c-1e0a-e053-2a91aa0a6f43	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
61554-100-01	61554010001	28.3 g in 1 TUBE	28.3 g	Historical
61554-100-02	61554010002	453.6 g in 1 JAR	453.6 g	Historical