FDA.reportPublic FDA data

Health Smart Medicated Body

Product NDC
52862-030
11-digit product format
528620030
Labeler code
52862
Product ID
52862-030_299b0d45-09ec-7739-e063-6394a90a0abe
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
International Wholesale Inc dba Home Smart Products
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-27
Substance
MENTHOL; ZINC OXIDE
Active strength
.15; 1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Health Smart Medicated Body
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.15 g/100g
ZINC OXIDE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577232Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
044870e2-ebac-a095-e063-6294a90a2751Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-030-01Health Smart Medicated Body283 g in 1 BOTTLEPOWDER2836

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-030HEALTH SMART MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [INTERNATIONAL WHOLESALE INC DBA HOME SMART PRODUCTS]6Current NDC, 1 package rows20241222_044870e2-ebac-a095-e063-6294a90a2751.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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
application number: M016
health beyond VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.de87da51-cf92-402c-b60f-5f28d17241242025-11-23WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP00766a7b-797e-dd15-e063-6394a90af9ac2025-11-20WarningsExact identifier
application number: M016
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
application number: M016
Moisture Barrier CreamPETROLATUM, ZINC OXIDEDerma Sciences Canada Inc.43e01e22-7872-8e24-e063-6394a90a17ef2025-11-18WarningsExact identifier
application number: M016
terrasil Bed Sore and Pressure Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsd0e4a492-f833-4e92-bd4a-b0a07ce9a69e2025-11-18WarningsExact identifier
application number: M016
terrasil Foot Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2776080b-3ddb-ad6c-e063-6394a90a93e02025-11-18WarningsExact identifier
application number: M016
After Bite KidsSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands226c1420-d771-204f-e063-6294a90af9f62025-11-18WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)280d4bdb-30d3-44f2-9159-3aa9a1de9a5f2025-11-17WarningsExact identifier
application number: M016
After Bite X TechSODIUM BICARBONATEAdventure Ready Brandse9e49ab4-3e1f-9fd4-e053-2a95a90a775a2025-11-17WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
application number: M016
DERMOGENZINC OXIDEKRAMER NOVIS38e02d1c-c143-4da6-ad32-a3ce2861aac52025-11-14WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Rapid Relief Rash CreamPETROLATUM, ZINC OXIDEWelmedix LLC4382a6b4-0b1f-0822-e063-6394a90adffc2025-11-14WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)086b6563-cb73-4874-aa42-028f5e81b60d2025-11-13WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC43840785-3640-9813-e063-6394a90a77702025-11-13WarningsExact identifier
application number: M016
Petroleum Jelly Baby Fresh Scent 3.53ozPETROLATUMRejoice International Corp.1309926f-ecd9-635e-e063-6294a90aaab32025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Fragrance Free 3.53ozPETROLATUMRejoice International Corp.12f8d9cc-aa77-e034-e063-6394a90a94dd2025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53ozPETROLATUMRejoice International Corp.1309b15b-5236-6e9f-e063-6294a90afe112025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Tremella Revitalizing CleanserTREMELLA FUCIFORMIS WHOLEODLUMIVIE435e4736-bcef-c227-e063-6394a90a53d52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Peptide CalmMistPALMITOYL TRIPEPTIDE-8ODLUMIVIE435e6717-5fbf-5cb2-e063-6294a90a40d72025-11-11WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN044870e2-ebac-a095-e063-6294a90a27516
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD044870e2-ebac-a095-e063-6294a90a27516
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY044870e2-ebac-a095-e063-6294a90a27516
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY044870e2-ebac-a095-e063-6294a90a27516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52862-030-0152862003001283 g in 1 BOTTLE (52862-030-01) 283 g2020-08-01NoNoCurrent