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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier application number: M016
Dimethicone	BODY CLEANSER	McKesson	8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8	2024-06-14	Warnings	Exact identifier application number: M016
Dr. Mom Butt Balm	DIMETHICONE PETROLATUM	Ferndale Laboratories, Inc.	ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd	2024-06-13	Warnings	Exact identifier application number: M016
Secura Protective	PETROLATUM	Smith & Nephew Medical Ltd	20906566-fbf2-46d9-a5d8-c7f7356d1080	2024-06-12	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier application number: M016
CVS Health Vitamin A and D Skin Protectant	LANOLIN AND PETROLATUM	CVS Health	fe3ccabb-9644-4091-9dca-ffd96a43ecaf	2024-05-28	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	186a9642-cd73-adfb-e063-6394a90a75c7	2024-05-14	Warnings	Exact identifier application number: M016
Honest Eczema Balm	COLLOIDAL OATMEAL	The Honest Company, Inc.	35b8bc5c-420e-4d31-9659-f36cabbd897a	2024-05-14	Warnings	Exact identifier application number: M016
Extra Strength Itch Stopping	ITCH STOPPING CREAM	Universal Distribution Centre LLC	b9a42aa3-1903-76f0-e053-2a95a90a51d1	2024-05-13	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Cardinal Health, 110 dba Leader	7f733c0a-82b2-d3b0-e053-2991aa0a6b0f	2024-05-13	Warnings	Exact identifier application number: M016
Walgreens Maximum Diaper Rash	ZINC OXIDE	Walgreens Company	5eb2152f-6fa2-4191-878a-207416e69818	2024-05-07	Warnings	Exact identifier application number: M016
Cetaphil Eczema Rapid Relief Cream	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	02a405fa-8ae9-41e9-b86f-ef5fb6e3844a	2024-05-02	Warnings	Exact identifier application number: M016
Chapstick	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	0e34fc74-772e-48fd-a353-58807ef412c1	2024-05-01	Warnings	Exact identifier application number: M016
Diaper Rash Cream 40% ZINC	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	16da985a-6210-ec82-e063-6294a90a132d	2024-04-24	Warnings	Exact identifier application number: M016
Petrolatum Jelly	PETROLATUM	ASTONEA LABS PRIVATE LIMITED	16dac8e5-aeb8-592d-e063-6394a90ae2b6	2024-04-24	Warnings	Exact identifier application number: M016
Monistat Complete Care Chafing Relief	DIMETHICONE	Insight Pharmaceuticals LLC	07d7c883-1fa3-4786-905c-a1fab649765e	2024-04-19	Warnings	Exact identifier application number: M016
zinc oxide 20%	ZINC OXIDE 20%	Bionpharma Inc	1549500a-0941-0fba-e063-6394a90a564e	2024-04-18	Warnings	Exact identifier application number: M016
ARC Skin Protectant	ALLANTOIN	Anjon Biologics, Inc	f4ff79dd-cb38-4cca-9631-a2758a171873	2024-04-18	Warnings	Exact identifier application number: M016
Zinctral	ZINC OXIDE	PureTek Corporation	de990834-00da-0c7a-e053-2995a90a7c37	2024-04-15	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Variety Pack	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	bfb9a2d5-1ad2-45b8-a215-9d1370af5337	2024-04-12	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