FDA.reportPublic FDA data

Amerfresh Medicated Body Powder

Product NDC
87510-001
11-digit product format
875100001
Labeler code
87510
Product ID
87510-001_5cb83d87-75a4-ca97-e063-6394a90ad098
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
ONEST LIMITED
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-25
Marketing end
2027-10-01
Substance
MENTHOL; ZINC OXIDE
Active strength
.15; 1 g/100g; g/100g
NDC exclude flag
No
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
Amerfresh Medicated Body Powder

Active Ingredients#

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

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
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
87510-001-01Amerfresh Medicated Body Powder285 g in 1 BOTTLEPOWDER2851

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 66 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC1ac9ee69-339d-4426-b3bf-13e5386f1a9b2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCcf888bf3-6950-43aa-b4be-5a32961b4d962023-11-15WarningsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCb6e0ddb8-3761-482a-83d0-15d612d142eb2023-11-15WarningsExact identifier
application number: M016
DERMA SANTE Anti Eczema CreamOATMEALHope Science Inc.1492a6ad-016c-4307-8286-5c564de9e1602023-11-11WarningsExact identifier
application number: M016
M3 NATURALS Eczema CreamOATMEALM3 Naturals LLC45e2cdde-58fb-4eea-a54d-f53f9ad0d8542023-11-11WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC53900588-5c9e-4164-816d-017bdbb0f31b2023-11-11WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash Max StrengthZINC OXIDEGeodis Logistics LLC1b4fd6cb-f2dc-40a2-b958-e99caec917932023-11-10WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash OriginalZINC OXIDEGeodis Logistics LLC97587458-4ca0-4de3-9bb9-148346d859c02023-11-10WarningsExact identifier
application number: M016
EltaMD Laser BalmPETROLATUM SKIN PROTECTANTCP Skin Health Group, Inc1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb2023-11-09WarningsExact identifier
application number: M016
DiaperDerm Diaper RashZINC OXIDEDiaperderm Inc4e1fce3e-c2b7-42da-9953-1dbb13e2467c2023-11-06WarningsExact identifier
application number: M016
Doctors Diaper Rash CreamZINC OXIDEDOCTOR'S DIAPER RASH CREAM, INC0988ccb1-7881-4d97-bcbf-d0cf4316e4be2023-11-06WarningsExact identifier
application number: M016
DERMOIA Manuka Honey Eczema CreamOATMEALTREASUREWISE LLCa48e52a3-b681-4489-a1fd-6b09d8bc9c552023-11-06WarningsExact identifier
application number: M016
GL HEALTH Barrier Skin ProtectantZINC OXIDEGL HEALTH, INC.76cfa330-fea9-48d4-b187-469154765d392023-11-06WarningsExact identifier
application number: M016
Skin-lubePETROLATUM, DIMETHICONEThe Hygenic Company, LLC.d1005dec-04f6-3f88-e053-2a95a90ad9cb2023-11-05WarningsExact identifier
application number: M016
Dr. Sheffield Anti Itch CreamANTI ITCH CREAMSheffield Pharmaceuticals LLC77f0593e-f694-4c02-9fd9-ad56ff2a920c2023-10-30WarningsExact identifier
application number: M016
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN8bef552b-b110-4663-9347-f8dba96c8d531
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD8bef552b-b110-4663-9347-f8dba96c8d531
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY8bef552b-b110-4663-9347-f8dba96c8d531
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY8bef552b-b110-4663-9347-f8dba96c8d531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
87510-001-0187510000101285 g in 1 BOTTLE (87510-001-01) 285 g2026-04-252027-10-01NoNoHistorical