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 149 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FEEL GOOD LABS NATURAL PAIN MENTHOL The Feel Good Lab 778b62a1-ebd3-4a30-8f76-6d6773b698c5 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL The Feel Good Lab 103c5e33-42fb-41ac-957e-bb46d85e204c 2023-11-05 Warnings Exact identifier application number: M017 INSTA RELIEF DM LIDOCAINE HYDROCHLORIDE, MENTHOL DM LAB CORP 6ef66fb9-9f49-409d-9503-175c7555ee9e 2023-11-05 Warnings Exact identifier application number: M017 DR. MIKES Ponos Pain Relief Cream Roll-On HISTAMINE DIHYDROCHLORIDE, MENTHOL Dr. Mike's Vitamins, LLC fcc45464-f1fe-4244-95a7-9b4288b0ce45 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Pain Relief MENTHOL Innovations for Wellness, LLC 7f222a4f-85a8-4f3d-aa97-5c695d4da37f 2023-11-05 Warnings Exact identifier application number: M017 Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL THE FEEL GOOD LAB, LLC 19b08cbf-5f43-4f07-8f4d-8cddb1492ab8 2023-11-05 Warnings Exact identifier application number: M017 PlayMakar Roll On Cool Pain Relief MENTHOL PlayMakar Inc. a12c16e7-561f-45a7-93c6-34d693ffdc7c 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Advanced Therapy for Pain and Recovery MENTHOL INNOVATIONS FOR WELLNESS, LLC 840cfd15-4ea1-49bf-8c4f-86c12461d860 2023-11-05 Warnings Exact identifier application number: M017 SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE ScleraCare, LLC 488ace02-fc0b-4d13-ab89-0e1640e915e5 2023-11-05 Warnings Exact identifier application number: M017 IRELIEV ROLL ON COOL PAIN RELIEF MENTHOL Excel Health, Inc dab94995-7393-4d9c-b295-72611a90919b 2023-11-05 Warnings Exact identifier application number: M017 URIFLEX Fast Acting Analgesic Pain Relief MENTHOL Rejuvica LLC fb78f705-b838-461d-b42c-8c98d3ca5d09 2023-11-05 Warnings Exact identifier application number: M017 365 Medicated Lip Balm MEDICATED LIP BALM Whole Foods Market, Inc. 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 2023-11-03 Warnings Exact identifier application number: M017 COOL BREEZE Pain Relief MENTHOL COOL BREEZE US LLC 14dcf4ee-6778-49d4-8601-9205737432ea 2023-11-01 Warnings Exact identifier application number: M017 Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Proficient Rx LP 1ebb45e5-4541-4c95-abe1-661ef763a610 2023-11-01 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Cream LIDOCAINE 4% Walgreens ce1b55ed-f5c5-ea8b-e053-2a95a90acd40 2023-10-31 Warnings Exact identifier application number: M017 Walgreens pain relieving LIDOCAINE 4% Walgreens ce2b9e57-749d-715c-e053-2995a90aaf8d 2023-10-31 Warnings Exact identifier application number: M017 Walgreens Cool n heat LIDOCAINE 4% MENTHOL 1% Walgreens ce168ab7-ec4a-daea-e053-2995a90af829 2023-10-31 Warnings Exact identifier application number: M017 Methyl Salicylate 40 Percent METHYL SALICYLATE Alexso, Inc 53407aab-094c-4393-a2b9-54fd85321e3e 2023-10-31 Warnings Exact identifier application number: M017 Hydrocortisone Acetate HYDROCORTISONE ACETATE Bentlin Products LLC 4346351c-8e11-46ae-b428-98d17f55beb9 2023-10-30 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