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 40 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch Relief GelDIPHENHYDRAMINE HCLWalgreens487060a7-dff3-4840-b967-ca919f8d0a292026-01-15WarningsExact identifier
application number: M017
Walgreen Itch Relief GelDIPHENHYDRAMINE HYDROCHLORIDEWalgreens5aca3297-406f-4165-9895-c58ccffb374f2026-01-15WarningsExact identifier
application number: M017
Pain Relieving PatchLIDOCAINEFlexiGo Inc.4868af2a-c4be-9c68-e063-6394a90a565b2026-01-15WarningsExact identifier
application number: M017
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
application number: M017
Careland Lidocaine 4 Pain Relieving Gel-PatchesLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6ca8382-7ce5-4df9-912e-8a0ac04231162026-01-15WarningsExact identifier
application number: M017
Neuropathy CreamMENTHOL CREAMOwell Naturals Brand, LLC48739205-627b-41d0-e063-6394a90a34622026-01-15WarningsExact identifier
application number: M017
BLT 1BENZOCAINECENTURA PHARMACEUTICALS INC3eea2171-850b-4045-e054-00144ff8d46c2026-01-15WarningsExact identifier
application number: M017
Icy Hot Lidocaine DryLIDOCAINE, MENTHOLChattem, Inc.d500a74e-ab93-4919-8665-a89e9d4cad282026-01-15WarningsExact identifier
application number: M017
Cortizone 10 Bug Bite Relief1% HYDROCORTISONEChattem, Inc.b21b6c04-8246-4567-98cf-64e8c588e79c2026-01-15WarningsExact identifier
application number: M017
Gold Bond Intensive Relief Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLChattem, Inc.e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f82026-01-14WarningsExact identifier
application number: M017
Cortizone-10 Soothing Aloe CremeHYDROCORTISONEChattem, Inc.1a841bf0-9d7b-4566-b442-aa9bcc8278462026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Sensitive Skin CremeHYDROCORTISONEChattem, Inc.b139917c-00bb-4cb3-995d-a6d2f2c295c62026-01-14WarningsExact identifier
application number: M017
Cortizone 10 for PsoriasisHYDROCORTIZONEChattem, Inc.fad9eedb-95e1-4e1a-91e5-0bfd077e0cf52026-01-14WarningsExact identifier
application number: M017
Pain Relief Roll OnTOPICAL ANALGESICEagle Labs Inc2380a400-062a-4a8d-a594-a2e0972190442026-01-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINE 4%AvKARE70aace2f-47b4-e961-e053-2991aa0a63672026-01-14WarningsExact identifier
application number: M017
JUST CBD - ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLC485f355a-4458-67b6-e063-6394a90ab2a02026-01-14WarningsExact identifier
application number: M017
Relief Pain Relieving CreamMENTHOLCorganics, LP85814fff-35f8-447f-b669-87eaf55e98592026-01-14WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub CherryCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company486269c9-af3a-7856-e063-6294a90a378c2026-01-14WarningsExact identifier
application number: M017
Mentholatum Vapor MaxCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company4863606f-f7c8-b4a4-e063-6294a90a11382026-01-14WarningsExact identifier
application number: M017
Hydrocortisone Cream Intensive HealingHYDROCORTISONE CREAMWalgreens8a3f486c-1353-466d-9ea7-c14559b53bf32026-01-14WarningsExact 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