FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.44 g/100g
ZINC OXIDE20.625 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, SOI2LOH54Z
Rxcui2123045

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-013-232025-01-06C16284748780-11030e365-237a-111a-e063-dadaa90a10e2GG Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant
69771-013-232024-01-30C16284748780-11030e365-237a-111a-e063-dadaa90a10e2GG 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 NDCProductDescriptionFormQuantityStrengthSPL version
69771-013-23Menthol and Zinc Oxide113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-013MENTHOL AND ZINC OXIDE OINTMENT [GERI-GENTLE CORPORATION]3Current NDC, Legacy NDC, 1 package rows20250108_e673d8bd-2573-9f04-e053-2995a90a172a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSNe673d8bd-2573-9f04-e053-2995a90a172a3
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCDe673d8bd-2573-9f04-e053-2995a90a172a3
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSYe673d8bd-2573-9f04-e053-2995a90a172a3
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSYe673d8bd-2573-9f04-e053-2995a90a172a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69771-013-2369771001323113 g in 1 TUBE (69771-013-23) 113 g2022-08-170000-00-00NoNoCurrent