FDA.reportPublic FDA data

Menthol and Zinc Oxide

Product NDC
67777-234
11-digit product format
677770234
Labeler code
67777
Product ID
67777-234_2758f00d-dee3-2463-e063-6294a90a53c2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-11
Substance
MENTHOL; ZINC OXIDE
Active strength
.44; 21 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 OXIDE21 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, SOI2LOH54Z
Rxcui2123045

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-234-01Menthol and Zinc Oxide2 in 1 CASEOINTMENT213
67777-234-02Menthol and Zinc Oxide3.5 g in 1 POUCHOINTMENT3.513
67777-234-02Menthol and Zinc Oxide144 in 1 BOXOINTMENT14413
67777-234-03Menthol and Zinc Oxide24 in 1 CASEOINTMENT2413
67777-234-04Menthol and Zinc Oxide113 g in 1 TUBEOINTMENT11313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-234-01GM - Gram67777-23446f9f4ca-c053-4d24-b2ad-3d98604bd9a112022-06-06
67777-234-02GM - Gram67777-234447b76a9-1e77-4aff-88fa-1bb5ade63fa612023-06-06
67777-234-03GM - Gram67777-234f5554336-50ce-465f-b28a-6f0c6606a3a912022-06-06
67777-234-04GM - Gram67777-234fc3d4854-e037-46ea-a476-8d37a8173e1d12023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
MENTHOLACTIVE MOIETYL7T10EIP3AMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
LANOLININACTIVE INGREDIENT7EV65EAW6HMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
PHENOLINACTIVE INGREDIENT339NCG44TVMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4
THYMOLINACTIVE INGREDIENT3J50XA376EMENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-234MENTHOL AND ZINC OXIDE OINTMENT [DYNAREX CORPORATION]13Current NDC, Legacy NDC, 5 package rows20241122_d0e43651-4215-465b-9ace-1bc23126b109.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSNd0e43651-4215-465b-9ace-1bc23126b10913
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCDd0e43651-4215-465b-9ace-1bc23126b10913
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSYd0e43651-4215-465b-9ace-1bc23126b10913
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSYd0e43651-4215-465b-9ace-1bc23126b10913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-234-01677770234012 BOX in 1 CASE (67777-234-01) / 144 POUCH in 1 BOX (67777-234-02) / 3.5 g in 1 POUCH2 box2010-05-110000-00-00NoNoCurrent
67777-234-02677770234023.5 g in 1 POUCH3.5 gHistorical
67777-234-036777702340324 TUBE in 1 CASE (67777-234-03) / 113 g in 1 TUBE (67777-234-04) 24 tube2010-05-110000-00-00NoNoCurrent
67777-234-0467777023404113 g in 1 TUBE113 gHistorical