Menthol and Zinc Oxide

Product NDC: 67777-409
11-digit product format: 677770409
Labeler code: 67777
Product ID: 67777-409_eb1c3ee3-da0c-4fc9-b9ca-dae83ae09492
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol and Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Dynarex Corporation
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-10-11
Marketing end: 0000-00-00
Substance: MENTHOL; ZINC OXIDE
Active strength: 0 g/100g; g/100g
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67777-409		I	Inactivated by FDA	2026-10-05
excluded package	package	67777-409	67777-409-01	I	Inactivated by FDA	2026-10-05
excluded package	package	67777-409	67777-409-02	I	Inactivated by FDA	2026-10-05
excluded package	package	67777-409	67777-409-03	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 2 · 88 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	67777-409-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-409-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-409-01	`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	67777-409-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-409-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-409-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-409-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-409-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-409-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-409-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-409-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-409-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-409-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-409-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-409-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-409-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-409-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-409-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-409-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-409-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-409-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-409-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-409-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-409-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-409-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-409-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-409-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67777-409-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67777-409-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67777-409-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67777-409-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67777-409-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67777-409-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67777-409-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67777-409-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67777-409-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67777-409-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67777-409-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67777-409-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67777-409-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67777-409-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67777-409-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67777-409-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67777-409-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67777-409-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67777-409-01	2020-01-31	C162847	48780-1	9d75b9d0-91a5-f424-e053-dadaa90a57ce	Calasoothe Ointment
67777-409-02	2020-01-31	C162847	48780-1	9d75b9d0-91a5-f424-e053-dadaa90a57ce	Calasoothe Ointment
67777-409-03	2020-01-31	C162847	48780-1	9d75b9d0-91a5-f424-e053-dadaa90a57ce	Calasoothe Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67777-409-01	Menthol and Zinc Oxide	3.5 g in 1 POUCH	OINTMENT	3.5	1
67777-409-02	Menthol and Zinc Oxide	71 g in 1 JAR	OINTMENT	71	1
67777-409-03	Menthol and Zinc Oxide	113 g in 1 TUBE	OINTMENT	113	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1
THYMOL	INACTIVE INGREDIENT	3J50XA376E	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-409	MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	1	Legacy NDC, 3 package rows	20141011_fa1feac2-a28c-4bc1-bbf0-aeee74ac607f.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	fa1feac2-a28c-4bc1-bbf0-aeee74ac607f	1
2123045	menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment	SCD	fa1feac2-a28c-4bc1-bbf0-aeee74ac607f	1
2123045	Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment	SY	fa1feac2-a28c-4bc1-bbf0-aeee74ac607f	1
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	SY	fa1feac2-a28c-4bc1-bbf0-aeee74ac607f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67777-409-01	67777040901	3.5 g in 1 POUCH	3.5 g	Historical
67777-409-02	67777040902	71 g in 1 JAR	71 g	Historical
67777-409-03	67777040903	113 g in 1 TUBE	113 g	Historical