FDA.reportPublic FDA data

AXE BRAND MEDICATED

Product NDC
57538-003
11-digit product format
575380003
Labeler code
57538
Product ID
57538-003_5d2fe434-38d3-6680-e063-6394a90a564c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR AND METHYL SALICYLATE
Dosage form
OIL
Route
TOPICAL
Labeler
LEUNG KAI FOOK MEDICAL CO PTE LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-26
Marketing end
2031-05-31
Substance
MENTHOL; CAMPHOR (SYNTHETIC); METHYL SALICYLATE
Active strength
16; 5; 15 g/100mL; g/100mL; g/100mL
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
AXE BRAND MEDICATED

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL16 g/100mL
CAMPHOR (SYNTHETIC)5 g/100mL
METHYL SALICYLATE15 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57538-003-01AXE BRAND MEDICATED56 mL in 1 PACKAGEOIL565

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETAXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AAXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YAXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETAXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
MENTHOLACTIVE MOIETYL7T10EIP3AAXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZAXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPAXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57538-003AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD]3Current NDC, Legacy NDC, 1 package rows20241127_e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0.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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
application number: M017
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
application number: M017
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
application number: M017
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
application number: M017
Arthritis Relief GoodSenseTROLAMINE SALICYLATEGeiss, Destin & Dunn, Inca253730a-2187-07de-e053-2a95a90a98772020-04-02WarningsExact identifier
application number: M017
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited567b6820-fb52-630e-e063-6294a90a8bf82015-07-01WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601879camphor 5 % / menthol 16 % / methyl salicylate 15 % Topical OilPSNe4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b05
1601879camphor 50 MG/ML / menthol 160 MG/ML / methyl salicylate 150 MG/ML Topical OilSCDe4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b05
1601879camphor 5 % / menthol 16 % / methyl salicylate 15 % Medicated OilSYe4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b05
1601879camphor 5 % / menthol 16 % / methyl salicylate 15 % Topical OilSYe4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57538-003-015753800030156 mL in 1 PACKAGE (57538-003-01) 56 ml2026-05-262031-05-31NoNoCurrent