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 11 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daily Moisturizing	DIMETHICONE	Aldi, Inc	118a1a07-7283-4353-97b5-6ac3b1cc1430	2026-05-08	Warnings, Adverse reactions	Exact identifier application number: M016
Dove	ANTIBACTERIAL CARE MOISTURIZING CREAM	Conopco Inc. d/b/a/ Unilever	5150f48c-ff0c-ce39-e063-6394a90ad424	2026-05-08	Warnings	Exact identifier application number: M016
Seedlings Diaper Rash Cream	ZINC OXIDE	Young Living Essential Oils, LC.	4d8aeaba-ddb1-6f74-e054-00144ff88e88	2026-05-08	Warnings	Exact identifier application number: M016
Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5120b708-047a-1182-e063-6394a90a74c3	2026-05-06	Warnings	Exact identifier application number: M016
AOAO Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	512185a5-5c1d-ef9f-e063-6394a90a81af	2026-05-06	Warnings	Exact identifier application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENT	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5121c341-e5e9-2b36-e063-6394a90a93b8	2026-05-06	Warnings	Exact identifier application number: M016
Beyond Good Diaper Rash	ZINC OXIDE	Babylist, Inc	512b62df-4f08-d839-e063-6294a90ab52f	2026-05-06	Warnings	Exact identifier application number: M016
Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	4c531280-bc5b-1cf2-e063-6394a90a034a	2026-05-05	Warnings	Exact identifier application number: M016
PEGO Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	511eaced-c4d8-ae94-e063-6394a90a320e	2026-05-05	Warnings	Exact identifier application number: M016
Rugby Gas relief	SIMETHICONE	Rugby Laboratories	9b84f74f-8609-489d-b411-3103afa1b5c2	2026-05-04	Warnings	Exact identifier application number: M016
Vitamin A and D	PETROLATUM	Aldermed Inc.	3f13a15c-8b64-48f0-a459-853b9097bc31	2026-05-04	Warnings	Exact identifier application number: M016
Zinc Oxide Skin Protectant	ZINC OXIDE 20%	Aldermed Inc.	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	2026-05-04	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Aldermed Inc.	4e02af41-db86-46d8-a97d-332d84eced6f	2026-05-04	Warnings	Exact identifier application number: M016
Daily Moisturizer	LOTION	Walgreens	fc65f673-b23d-1ffa-e053-6394a90a0966	2026-05-03	Warnings	Exact identifier application number: M016
Dry Skin Healing	PETROLATUM	Walgreen	0397507d-4b6e-c679-e063-6294a90a0b33	2026-05-03	Warnings	Exact identifier application number: M016
Daily Moisturizer	LOTION	Walgreen	fc67037a-ed31-f678-e053-6394a90a7175	2026-05-03	Warnings	Exact identifier application number: M016
Skin Relief	LOTION	Walgreen	fc678e80-e63d-e3fe-e053-6394a90aa7d6	2026-05-03	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Walmart INC	f76ceecc-ef11-3839-e053-6394a90a8d4a	2026-05-03	Warnings	Exact identifier application number: M016
Herpecin L	DIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONE	Focus Consumer Healthcare, LLC	5b6ed4e9-3e69-c773-e053-2991aa0a7dfe	2026-05-01	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Retail Business Services, LLC	7291e175-a9b6-4c47-93ce-227ce11e4599	2026-04-30	Warnings, Adverse reactions	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