ZINC-OXYDE PLUS

Product NDC: 75983-006
Requested package NDC: 75983-006-57
11-digit product format: 759830006
Labeler code: 75983
Product ID: 75983-006_d8c30b8c-dac8-183a-e053-2a95a90a6a54
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, ZINC OXIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: First Aid Research Corp.
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-11-06
Marketing end: 0000-00-00
Substance: MENTHOL; ZINC OXIDE
Active strength: 4 mg/g; mg/g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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	75983-006	75983-006-57	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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
75983-006-57	2024-01-30	C162847	48780-1	d6a99b39-8537-a426-e053-dadaa90af4c2	Zinc Oxide Plus
75983-006-57	2022-02-24	C162847	48780-1	d6a99b39-8537-a426-e053-dadaa90af4c2	Zinc Oxide Plus
75983-006-57	2022-01-28	C162847	48780-1	d6a99b39-8537-a426-e053-dadaa90af4c2	Zinc Oxide Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75983-006-57	ZINC-OXYDE PLUS	57 g in 1 TUBE	OINTMENT	57		3
75983-006-57	ZINC-OXYDE PLUS	1 in 1 CARTON	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75983-006	ZINC-OXYDE PLUS (MENTHOL, ZINC OXIDE) OINTMENT [FIRST AID RESEARCH CORP.]	3	Legacy NDC, 2 package rows	20220225_cbd899ca-80da-4a1b-9b32-2148759d9424.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
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	PSN	cbd899ca-80da-4a1b-9b32-2148759d9424	3
2123045	menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment	SCD	cbd899ca-80da-4a1b-9b32-2148759d9424	3
2123045	Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment	SY	cbd899ca-80da-4a1b-9b32-2148759d9424	3
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	SY	cbd899ca-80da-4a1b-9b32-2148759d9424	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75983-006-57	75983000657	1 TUBE in 1 CARTON (75983-006-57) > 57 g in 1 TUBE	1 tube	2019-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide Plus	First Aid Research Corp. \| Anicare Pharmaceuticals Pvt. Ltd	2022-02-24	HUMAN OTC DRUG LABEL	3