FDA.reportPublic FDA data

Health Smart Medicated Body

Product NDC
52862-020
Requested package NDC
52862-020-22
11-digit product format
528620020
Labeler code
52862
Product ID
52862-020_ac9d655f-6efa-c4a6-e053-2a95a90a14b6
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
International Wholesale Inc dba Home Smart Products
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-27
Marketing end
0000-00-00
Substance
MENTHOL; ZINC OXIDE
Active strength
0 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage52862-02052862-020-22EExcluded after deficient or non-compliant submission was not corrected2026-10-05

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52862-02052862-020-22IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52862-020-222020-08-11C16284748780-19d75b9d0-cd78-f424-e053-dadaa90a57ceHealth Smart Medicated Body Powder
52862-020-222020-01-31C16284748780-19d75b9d0-cd78-f424-e053-dadaa90a57ceHealth Smart Medicated Body Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-020-22Health Smart Medicated Body283 g in 1 BOTTLEPOWDER2834

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
MENTHOLACTIVE MOIETYL7T10EIP3AHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
ACACIAINACTIVE INGREDIENT5C5403N26OHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662HEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
THYMOLINACTIVE INGREDIENT3J50XA376EHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVHEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-020HEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]4Legacy NDC, 1 package rows20241222_3bf911c7-02f2-4744-ad87-452b24422ea9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN3bf911c7-02f2-4744-ad87-452b24422ea94
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD3bf911c7-02f2-4744-ad87-452b24422ea94
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY3bf911c7-02f2-4744-ad87-452b24422ea94
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY3bf911c7-02f2-4744-ad87-452b24422ea94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-020-2252862002022283 g in 1 BOTTLE (52862-020-22) 283 g2020-08-010000-00-00NoNoCurrent