Home NDC 57538-003 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 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 101 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menthol Pain Relief Gel-Roll On MENTHOL Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 0bd62de8-ce8b-c110-e063-6294a90a98cb 2025-02-07 Warnings Exact identifier application number: M017 Menthol Pain Relief Gel-Tube MENTHOL Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 0bb07892-824e-8691-e063-6294a90a3891 2025-02-07 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Olakino Therapeutics LLC 2a41a621-c6f7-5819-e063-6394a90ae67d 2025-02-07 Warnings Exact identifier application number: M017 Pain Reliveing Patch LIDOCAINE 4% simple diagnostics 02ed0b27-bba9-ec0c-e063-6294a90a014d 2025-02-07 Warnings Exact identifier application number: M017 FlexDermal Pain Relieving Roll-On MENTHOL SOLVADERM LLC d4d8050e-0761-4491-8635-39c806701eb5 2025-02-06 Warnings Exact identifier application number: M017 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE Clarion Brands LLC 2d7e9f6a-0f21-b103-e063-6294a90a912f 2025-02-06 Warnings Exact identifier application number: M017 signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE PHARMACURE LLC 8803ae01-ea48-46c2-ab64-bb273de605ac 2025-02-05 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 2d685602-5cd6-3b36-e063-6394a90a3c5d 2025-02-05 Warnings Exact identifier application number: M017 Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE PHARMACURE LLC 2c32cfed-2022-4e7c-ae9c-ba22dbb560af 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN PHARMACURE LLC b2b2de93-d957-43d7-a2a8-b46bcaea1f0d 2025-02-04 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream Extreme MENTHOL 16%, CAMPHOR 11% Telebrands Corp 2d54077e-4c8d-aaae-e063-6394a90adb41 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN NuCare Pharmaceuticals,Inc. fd90a67d-d60d-a849-e053-6394a90a2cc8 2025-02-04 Warnings Exact identifier application number: M017 Rugby Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals, Inc. 2d58c15a-5ddb-1b16-e063-6294a90a3fbb 2025-02-04 Warnings Exact identifier application number: M017 Cetilar MENTHOL 1.4% PharmaNutra Usa Corp. 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59 2025-02-04 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. 0d199d39-5b47-4c7f-b83a-757f39aa17b6 2025-02-03 Warnings Exact identifier application number: M017 TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Muscle METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) Haw Par Healthcare Ltd. 96b06d3f-8685-4314-ad7d-5d2720f4dde6 2025-02-03 Warnings Exact identifier application number: M017 Icy Hot Medicated No Mess Applicator MENTHOL Chattem, Inc. 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e 2025-02-01 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