Menthol and Zinc Oxide

Product NDC: 69771-013
11-digit product format: 697710013
Labeler code: 69771
Product ID: 69771-013_2b0e344b-8e5b-2995-e063-6394a90a9cbc
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol and Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: GERI-GENTLE CORPORATION
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-08-17
Substance: MENTHOL; ZINC OXIDE
Active strength: .44; 20.625 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
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	69771-013-23	`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	69771-013-23	`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	69771-013-23	`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	69771-013-23	`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	69771-013-23	`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	69771-013-23	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Menthol and Zinc Oxide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	.44 g/100g
ZINC OXIDE	20.625 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2123045	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e673d8bd-2573-9f04-e053-2995a90a172a	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69771-013-23	2025-01-06	C162847	48780-1	1030e365-237a-111a-e063-dadaa90a10e2	GG Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant
69771-013-23	2024-01-30	C162847	48780-1	1030e365-237a-111a-e063-dadaa90a10e2	GG Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69771-013-23	Menthol and Zinc Oxide	113 g in 1 TUBE	OINTMENT	113		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69771-013	MENTHOL AND ZINC OXIDE OINTMENT [GERI-GENTLE CORPORATION]	3	Current NDC, Legacy NDC, 1 package rows	20250108_e673d8bd-2573-9f04-e053-2995a90a172a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EELHOE Cuticle Pusher Pen	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	52c7f956-a2a1-ae1d-e063-6294a90ab3c2	2026-05-27	Warnings	Exact identifier application number: M016
Dermoia Eczema Relief Colloidal Oatmeal	OATMEAL	Treasurewise LLC	1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a	2026-05-27	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Wal-Mart Stores, Inc.	61e76e2a-fc46-7a64-e053-2991aa0a56a8	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Wal-Mart Stores, Inc.	61929c97-bd6b-0d7c-e053-2991aa0aa571	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Pharma Nobis, LLC	fbcfa541-beda-06de-e053-6294a90a9298	2026-05-26	Warnings	Exact identifier application number: M016
Humco Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Humco holding Group, Inc.	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	2026-05-26	Warnings	Exact identifier application number: M016
Advanced Healing	PETROLATUM	CVS Pharamacy, Inc	0bd3380e-2284-44a7-b2ef-68c9909627fd	2026-05-26	Warnings, Adverse reactions	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing Lip Balm	PETROLATUM	L'Oreal USA Products Inc	21dc8842-0672-4d46-bcea-b8e3d54c48bf	2026-05-20	Warnings	Exact identifier application number: M016
AFTER CARE	DIMETHICONE	Merz North America	c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae	2026-05-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	63b551fc-7d16-c099-e053-2a91aa0a5f2c	2026-05-18	Warnings	Exact identifier application number: M016
ADVANCED SILICONE SCAR	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	51ffdc45-5acf-ae20-e063-6294a90a55e8	2026-05-17	Warnings	Exact identifier application number: M016
LCFateLC Nail Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	51ea23f4-0a23-4ae1-e063-6394a90aa051	2026-05-16	Warnings	Exact identifier application number: M016
Radlive Active Defense Nano-Silver Cream	COLLOIDAL OATMEAL	SilverCeuticals	51e23135-008d-9db5-e063-6294a90a7d61	2026-05-15	Warnings	Exact identifier application number: M016
Cerave Developed with Dermatologists Healing	PETROLATUM	LOreal USA Products Inc	de44ac01-ba17-4f97-ac12-9ea348013bde	2026-05-14	Warnings	Exact identifier application number: M016
Triple 3x Max Diaper Rash	ZINC OXIDE	Advantice Health, LLC	e554046b-cd0a-4a6e-8f24-2e610c697432	2026-05-14	Warnings	Exact identifier application number: M016
Eczema Therapy	COLLOIDAL OATMEAL	SilverCeuticals	3a26a35e-a098-0e22-e063-6294a90a96b9	2026-05-13	Warnings	Exact identifier application number: M016
Nail- Pflaster	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	519681bc-6312-f627-e063-6394a90a2845	2026-05-11	Warnings	Exact identifier application number: M016
Hydrating	PETROLATUM	Aldermed Inc.	4aa6a354-e487-4b65-e063-6394a90abbf0	2026-05-09	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Aldermed Inc.	4aa79292-dc91-b538-e063-6294a90ac3f0	2026-05-09	Warnings	Exact identifier application number: M016
XIMONTH Nail Fungus Care Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	514a998d-aa2a-46b6-e063-6294a90a6c22	2026-05-08	Warnings	Exact identifier application number: M016

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	e673d8bd-2573-9f04-e053-2995a90a172a	3
2123045	menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment	SCD	e673d8bd-2573-9f04-e053-2995a90a172a	3
2123045	Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment	SY	e673d8bd-2573-9f04-e053-2995a90a172a	3
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	SY	e673d8bd-2573-9f04-e053-2995a90a172a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69771-013-23	69771001323	113 g in 1 TUBE (69771-013-23)	113 g	2022-08-17	0000-00-00	No	No	Current