FDA.reportPublic FDA data

Medicated Body

Product NDC
49035-295
Requested package NDC
49035-295-10
11-digit product format
490350295
Labeler code
49035
Product ID
49035-295_3af6617c-2131-49d5-8c3d-99d27cd3c253
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, ZINC OXIDE
Dosage form
POWDER
Route
TOPICAL
Labeler
Walmart Stores Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
MENTHOL; ZINC OXIDE
Active strength
3 mg/2g; mg/2g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-29549035-295-10IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-295-10Medicated BodyPowder283 g in 1 BOTTLEPOWDER2831

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-295MEDICATED BODY POWDER (MENTHOL, ZINC OXIDE) POWDER [WALMART STORES INC]1Legacy NDC, 1 package rows20161219_206cd4f9-5829-41aa-8187-16728bcabfd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN206cd4f9-5829-41aa-8187-16728bcabfd71
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD206cd4f9-5829-41aa-8187-16728bcabfd71
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY206cd4f9-5829-41aa-8187-16728bcabfd71
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY206cd4f9-5829-41aa-8187-16728bcabfd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-295-1049035029510283 g in 1 BOTTLE (49035-295-10) 283 g2009-09-010000-00-00NoNoCurrent