Home NDC 57538-003-01 AXE BRAND MEDICATED
Product NDC 57538-003
Requested package NDC 57538-003-01
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 Ingredient Strength MENTHOL 16 g/100mL CAMPHOR (SYNTHETIC) 5 g/100mL METHYL SALICYLATE 15 g/100mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57538-003-01 AXE BRAND MEDICATED 56 mL in 1 PACKAGE OIL 56 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAMPHOR (SYNTHETIC) ACTIVE INGREDIENT 5TJD82A1ET AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 CAMPHOR (SYNTHETIC) ACTIVE MOIETY 5TJD82A1ET AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 LAVENDER OIL INACTIVE INGREDIENT ZBP1YXW0H8 AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP AXE 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 NDC Dashboard title SPL version Validation Dashboard ZIP 57538-003 AXE BRAND MEDICATED (MENTHOL, CAMPHOR AND METHYL SALICYLATE) OIL [LEUNG KAI FOOK MEDICAL CO PTE LTD] 3 Current NDC, Legacy NDC, 1 package rows 20241127_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 59 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join POMG NIGHT TIME PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE POMG LLC 28d7dfb0-a94c-90de-e063-6294a90a036a 2025-12-02 Warnings Exact identifier application number: M017 Thermacare Max Strength Lidocaine THERMACARE MAX STRENGTH LIDOCAINE Clarion Brands LLC 44fed887-d1e0-d205-e063-6294a90ac416 2025-12-02 Warnings Exact identifier application number: M017 SUNSET COOLING PAIN RELIEF ROLL-ON MENTHOL SUNSET NOVELTIES, INC 45037bc1-aa03-11ae-e063-6294a90a6c96 2025-12-02 Warnings Exact identifier application number: M017 SUNSET HEATING PAIN RELIEF ROLL-ON CAMPHOR SUNSET NOVELTIES, INC 45048936-f3c9-25f7-e063-6394a90ac4a9 2025-12-02 Warnings Exact identifier application number: M017 CAREALL Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM New World Imports, Inc 3a01f57a-ebc6-4724-b625-1d1ea4b85e73 2025-12-01 Warnings Exact identifier application number: M017 CareALL Arthritis and Muscle CAPSAICIN New World Imports, Inc 4867eac4-00ea-434e-b289-1c1ef0342c23 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc e2df8130-e7c8-4fde-a6d6-c71378991213 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc d04e473d-8bbc-475c-a0b1-ca5eed67fbc7 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc cba7c084-379f-4a16-aeba-b11ca6e20d8a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc d066002d-8ceb-4d16-9744-d5ca25d2ad5a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Musle and Joint MENTHOL New World Imports, Inc 013beea4-b2c2-4e84-b4cb-3125ac48e8c0 2025-12-01 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN A2A Integrated Pharmaceuticals, LLC 147f3594-7362-7a78-e063-6294a90a3e42 2025-11-30 Warnings Exact identifier application number: M017 Aquanil HC HYDROCORTISONE Person and Covey 6b9258e4-c7c4-765e-e053-2991aa0a9f4e 2025-11-29 Warnings Exact identifier application number: M017 Walgreen Pain Relieving Fragrance Free LIDOCAINE HYDROCHLORIDE WALGREENS CO. 62c50ded-3fc9-4f65-9bfb-1144ed2e36b4 2025-11-26 Warnings Exact identifier application number: M017 Itch Relief ITCH RELIEF GEL Neilmed Pharmaceuticals Inc. 44811828-c32e-17fc-e063-6294a90add48 2025-11-26 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON Clarion Brands LLC 4482d34d-eaca-5522-e063-6394a90a6afb 2025-11-26 Warnings Exact identifier application number: M017 Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57538-003-01 57538000301 56 mL in 1 PACKAGE (57538-003-01) 56 ml 2026-05-26 2031-05-31 No No Current