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 56 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aveeno Daily Moisturizing	DIMETHICONE	Kenvue Brands LLC	70593b0c-c41b-4294-9bfa-42003ba1e3e4	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	029fbae2-06ad-4fe9-b542-834686c5cb97	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Overnight	DIMETHICONE	Kenvue Brands LLC	e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c	2024-11-05	Warnings	Exact identifier application number: M016
Quality Choice Diaper Rash	ZINC OXIDE	Chain Drug Marketing Association Inc.	262e7eac-4b44-f224-e063-6394a90a4f59	2024-11-05	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Chain Drug Marketing Association Inc.	262f8cab-c7b8-b07e-e063-6294a90a1289	2024-11-05	Warnings	Exact identifier application number: M016
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	926706b5-0a08-4604-b5ad-3b3ddfd7f02d	2024-11-05	Warnings	Exact identifier application number: M016
Walgreens Eczema Relief Body Skin Protectant	OATMEAL	Walgreen Company	b2eebc2f-addd-4822-b224-04bd5f450653	2024-11-05	Warnings	Exact identifier application number: M016
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	81eb3df4-5beb-45aa-82ca-e8b4b37e45f4	2024-11-05	Warnings, Adverse reactions	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	567b1481-b783-45f9-af38-5630c9edf044	2024-11-01	Warnings	Exact identifier application number: M016
ZO Skin Health Astringent Solution	ALUMINUM ACETATE	ZO Skin Health, Inc.	cb801d7e-52ad-6c16-e053-2a95a90a7a1f	2024-10-31	Warnings	Exact identifier application number: M016
ZINC OXIDE PHARMA	ZINC OXIDE	ALLIED TRADE LINK LLC	1b580bf6-f217-5c0f-e063-6294a90a012e	2024-10-29	Warnings	Exact identifier application number: M016
Dove DermaSeries Eczema Relief Soothing Body	COLLOIDAL OATMEAL	Conopco, Inc. d/b/a/ Unilever	59f737f6-dd3f-4b63-b13e-2345cb9a951a	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	a735d885-bacd-0f5c-e053-2a95a90ad14a	2024-10-24	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	b8dc481c-1ac3-2d63-e053-2a95a90a44f5	2024-10-24	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE HAND SANITIZER LOTION	Conopco Inc. d/b/a/ Unilever	ba0aa323-8887-597f-e053-2995a90a2077	2024-10-24	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	d1039316-3ca8-90f8-e053-2995a90a2061	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER LAVENDER	Conopco Inc. d/b/a/ Unilever	a736838b-b559-f066-e053-2995a90a90f5	2024-10-24	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	130d94d8-ad98-d61f-e063-6294a90a76b0	2024-10-21	Warnings	Exact identifier application number: M016
HARMON DAILY MOISTURZIER	DIMETHICONE	HARMON STORES, INC.	bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7	2024-10-21	Warnings	Exact identifier application number: M016
Dimethicone	BODY SHIELD	McKesson	8febb45d-a200-702c-e053-2995a90a3e62	2024-10-18	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