FDA.reportPublic FDA data

Menthol

Product NDC
81522-069
11-digit product format
815220069
Labeler code
81522
Product ID
81522-069_422aaf23-440e-34a8-e063-6294a90a215d
Type
HUMAN OTC DRUG
Nonproprietary name
Maximum Strength Medicated Foot Powder Talc Free
Dosage form
POWDER
Route
TOPICAL
Labeler
FSA Store Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-02
Substance
MENTHOL
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259579Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb3548c8-f202-dc50-e053-6394a90a5b30Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-069-01Menthol283 g in 1 BOTTLE, PLASTICPOWDER2834

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-069MENTHOL (MAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREE) POWDER [FSA STORE INC.]3Current NDC, 1 package rows20241109_fb3548c8-f202-dc50-e053-6394a90a5b30.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 143 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
application number: M017
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.b44beac3-1d20-434f-9a79-4fab1ac687912023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC79ad55eb-b59d-4bb8-88e3-3b51e10a7f282023-11-15WarningsExact identifier
application number: M017
PURE EASE Joint Muscle lnstant Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.42bf129c-5c84-4331-b6d0-78e3be71a9852023-11-13WarningsExact identifier
application number: M017
PURE EASE Neur Cream Instant Deep Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.e46a4636-6405-440a-a05a-862c354bab542023-11-13WarningsExact identifier
application number: M017
Cryomax CoolingMENTHOLLIFE WEAR TECHNOLOGIES0a0ae5ba-9fac-45f6-e063-6294a90ad5552023-11-13WarningsExact identifier
application number: M017
LBri Super Aloe Stop The PainMETHYL SALICYLATE, MENTHOL, CAPSAICINL'Bris, Pure 'N Natural8fb2010c-c34b-4552-858d-a0188ad313ad2023-11-11WarningsExact identifier
application number: M017
TOTAL RELIEFHYDROCORTISONEDR. MARDER SKINCARE, LLC2c05459c-5a2c-45ab-b534-87f966b416812023-11-11WarningsExact identifier
application number: M017
Human Science Muscle Pain ReliefMETHYL SALICYLATE, MENTHOLHuman Science, LLC4bccc017-264b-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLC55108ffd-d6a8-41de-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
Debbies Down and Dirty Deep Tissue Joint and MuscleMENTHOLDD&D Manufacturing Co., Ltd531fe834-53e3-305f-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
TerraFreeze Pain ReliefMENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDEBeyond Derma, LLC81dc70b3-7e93-4f9a-ae3a-b50bbfd1a6772023-11-11WarningsExact identifier
application number: M017
GOLD ICE Pain ReliefMENTHOLEden's Answers, Inc.a1356c39-42b9-4bd8-a873-bcd40717058b2023-11-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259579menthol 1 % Topical PowderPSNfb3548c8-f202-dc50-e053-6394a90a5b304
259579menthol 0.01 MG/MG Topical PowderSCDfb3548c8-f202-dc50-e053-6394a90a5b304
259579menthol 1 % Topical PowderSYfb3548c8-f202-dc50-e053-6394a90a5b304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81522-069-0181522006901283 g in 1 BOTTLE, PLASTIC (81522-069-01) 283 g2023-05-02NoNoCurrent