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 35 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5 Elementum Delay WipesBENZOCAINE DELAY WIPESMSVenturesGroup O440539b0-612b-3b41-e063-6294a90a1ddd2026-02-05WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION4a156400-7001-d00d-e063-6294a90aa7142026-02-05WarningsExact identifier
application number: M017
burnreliefLIDOCAINE HCLPublix Super Markets, Inc.9660f5e1-d39e-4f86-bf96-dff0f3bb729d2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLPublix Super Markets, Inc.fe442f1e-7045-481a-a501-d629bf568dfb2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Care Lix Pain ReliefSALICYLIC ACIDACQUIRED B SCALE LLC65dffffd-ede1-45e2-aa91-bdd5df2df6a62026-02-05WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.8075ba60-772c-4d1a-8584-722bb3e539be2026-02-05WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.51ce716e-b9f3-4e64-8c8e-17520d40f1922026-02-05WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.2b58058a-f350-4029-b039-117caf1c03732026-02-05WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLNantong Health & Beyond Hygienic Products Inc.7acc7282-ef4f-41ec-b51d-a88dfed79bd72026-02-05WarningsExact identifier
application number: M017
Cooling GelPAIN RELIEF COOLING GELNeilMed Pharmaceuticals Inc.49fb637b-ecc5-1f9b-e063-6294a90ab41a2026-02-04WarningsExact identifier
application number: M017
Medicaine Sting and BiteBENZOCAINEDynarex Corporationb721607e-e36b-4691-a824-c8f520bd63862026-02-04WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4a065965-43bd-e0e3-e063-6294a90ad76a2026-02-04WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a0969d3-1f06-3ba7-e063-6294a90a86272026-02-04WarningsExact identifier
application number: M017
Relief FlexMENTHOLBeone Co., Ltd.49e6f0ef-78fb-26fe-e063-6294a90a66552026-02-03WarningsExact identifier
application number: M017
NATURULZ ULTIMATE HEALINGCAPSAICINI SHAY COSMETICS INC436eac74-d07f-d718-e063-6394a90a86602026-02-03WarningsExact identifier
application number: M017
TheraCare Muscle and Join Pain Relieving CreamMENTHOL, METHYL SALICYLATEVeridian Healthcare18f9829e-c5f9-4253-e063-6394a90a70c62026-02-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INC8b8cdb26-8e8f-4e95-9d83-d685c90afe012026-02-02WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEEagle Indo Pharma, PT888f88fc-dcaf-93e5-e053-2a95a90a20e12026-02-02WarningsExact identifier
application number: M017
Wang Prom Green Balm by Wang PromWANG PROM WANG PROM GREEN BALM BY VENTURE GO LLCAMBIENCE FAMILY INC4a063898-16a4-695a-e063-6394a90adb932026-02-02WarningsExact 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