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 71 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Cold and Hot MENTHOL, AND METHYL SALICYLATE Safeway Inc. ab201023-e3dc-52ec-e053-2995a90a1f18 2025-10-24 Warnings Exact identifier application number: M017 HealthWise Medicated Cold Hot 5% Patch MENTHOL Veridian Healthcare 15aef56f-cd25-05ac-e063-6394a90a07bb 2025-10-23 Warnings Exact identifier application number: M017 Alivio LIDOCAINE Amerise Pharmaceuticals LLC eb3a98f1-c875-4f08-8b4b-44e22626b609 2025-10-23 Warnings Exact identifier application number: M017 Pain Relieveing Gel-Patch LIDOCAINE Bullet point LLC 41d507c4-ad37-2686-e063-6394a90aae5b 2025-10-23 Warnings Exact identifier application number: M017 ActivICE MENTHOL Medline Industries, LP 98fa9a34-0e1e-0997-e053-2a95a90ac77d 2025-10-23 Warnings Exact identifier application number: M017 Coralite Pain Relief Hot MENTHOL AND CAPSAICIN United Exchange Corporation 78eb133d-01bb-6466-e053-2991aa0accc0 2025-10-23 Warnings Exact identifier application number: M017 Americaine BENZOCAINE Insight Pharmaceuticals LLC 4fd14452-0285-40c4-b835-36935c2056b2 2025-10-23 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bc1c0c-63d5-0d41-e063-6394a90a341b 2025-10-22 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bd0769-6ba0-d0d5-e063-6294a90af7c9 2025-10-22 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Knee MENTHOL United Exchange Corp. aa5873bd-af64-41cc-8f16-7714c56bca96 2025-10-22 Warnings Exact identifier application number: M017 Family Care Muscle Rub CAMPHOR, MENTHOL, AND METHYL SALICYLATE United Exchange Corp. 63006bb5-76e8-eb64-e053-2991aa0a95ad 2025-10-22 Warnings Exact identifier application number: M017 Winco Cold and Hot Medicated Patch Large MENTHOL WINCO FOODS, LLC af0d86c4-f74e-2dbe-e053-2a95a90a74c1 2025-10-22 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 064a6149-a0e2-8a73-e063-6394a90a7953 2025-10-22 Warnings Exact identifier application number: M017 Topical Analgesic MENTHOL Youngevity International Inc. b4693947-f5b3-6fd3-e053-2995a90ab581 2025-10-22 Warnings Exact identifier application number: M017 PAIN RELIEVING LIDOCAINE Medhome Pharma Inc 41cb1135-84e0-0c9a-e063-6294a90ada96 2025-10-22 Warnings Exact identifier application number: M017 KINKAN AMMONIA, CAMPHOR (NATURAL), MENTHOL KINKANDO CO., LTD . f2c0f3e1-792b-4798-bf6d-acd1bbefa261 2025-10-21 Warnings Exact identifier application number: M017 Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 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