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
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 88 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tattoo	TATTOO CREAM	Perfso (HK) Co., Limited	39773cab-12df-4520-e063-6294a90abc5b	2025-07-08	Warnings	Exact identifier application number: M017
Neutrogena Sun Rescue After Sun Medicated Relief	CAMPHOR (SYNTHETIC)	Kenvue Brands LLC	c95c5b64-b90f-1143-e053-2a95a90aa03c	2025-07-07	Warnings	Exact identifier application number: M017
sunmark Hydrocortisone	HYDROCORTISONE	Strategic Sourcing Services LLC	210079e9-3d2f-4489-b468-b96b145034ed	2025-07-07	Warnings	Exact identifier application number: M017
Relief Gel	LIDOCAINE HCL	Good Clean Love, Inc.	e5fa2265-ccb7-750c-e053-2995a90aa51e	2025-07-07	Warnings	Exact identifier application number: M017
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	09ac2749-a60f-4039-8c80-a0d2eaf50c34	2025-07-07	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	2ada9ec2-1c28-4da2-8639-07b3193ffb32	2025-07-03	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	caa2fd64-e262-4d7c-ad8a-69f506feba8c	2025-07-03	Warnings	Exact identifier application number: M017
Stopain Extra Strength	MENTHOL	Troy Manufacturing, Inc.	07e9a235-6d10-4407-8729-beaf936e97ad	2025-07-03	Warnings	Exact identifier application number: M017
Blue Ice Topical Analgesic Gel	ICE GEL	International Wholesale	397cd306-078d-5b7d-e063-6294a90a8bbc	2025-07-03	Warnings	Exact identifier application number: M017
LIDOCAINE	LIDOCAINE, MENTHOL	Vive Health LLC	236ccc6d-21b7-6153-e063-6394a90a4634	2025-07-02	Warnings	Exact identifier application number: M017
AsperFlex MAX	LIDOCAINE 4% WITH MENTHOL 1%	Akron Pharma Inc.	ccf6172b-350a-4b78-b844-f84bf17c491f	2025-07-02	Warnings	Exact identifier application number: M017
METHYL SALICYLATE 25%	METHYL SALICYLATE	Oncora Pharma, LLC	3766e3a9-94a8-4c3e-e063-6394a90aa24a	2025-07-01	Warnings	Exact identifier application number: M017
Diphenhydramine Hydrochloride and Zinc Acetate	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Sun Pharmaceutical Industries, Inc.	c89e3de8-7d71-485c-8fc5-2832d6024f16	2025-07-01	Warnings	Exact identifier application number: M017
Westlake Outdoor Pain and Itch Relieving	LIDOCAINE 4% PAIN AND ITCH RELIEVING	WESTLAKE HB PHARMA	3c563b28-4f4f-9d0c-e063-6294a90adf73	2025-07-01	Warnings	Exact identifier application number: M017
Cortizone 10 Water Resistant	HYDROCORTISONE	Chattem, Inc.	118e55e7-241f-44c4-959e-09bf6221bd77	2025-07-01	Warnings	Exact identifier application number: M017
Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	38c1616e-3b09-0669-e063-6294a90a2c86	2025-06-29	Warnings	Exact identifier application number: M017
Plantar Fasciitis Cream	CAMPHOR	SOLALIA LLC	388f33c2-2bdf-ded8-e063-6294a90aeeac	2025-06-27	Warnings	Exact identifier application number: M017
4 Lidocaine Topical Anesthetic	LIDOCAINE	RUGBY LABORATORIES	63327e57-f4c8-4ae6-9d28-cef8697bbdcc	2025-06-27	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	ANTI-ITCH CONTINUOUS SPRAY	Wal-Mart Stores, Inc.	709c3bb8-5b36-4823-941a-45ddb3e431c4	2025-06-27	Warnings	Exact identifier application number: M017
Burn Relief Professional Bio-Kool	LIDOCAINE - 4%	Kool-Down Inc.	827e9c69-4706-0ccf-e053-2991aa0aa1c1	2025-06-27	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1601879	camphor 5 % / menthol 16 % / methyl salicylate 15 % Topical Oil	PSN	e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0	5
1601879	camphor 50 MG/ML / menthol 160 MG/ML / methyl salicylate 150 MG/ML Topical Oil	SCD	e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0	5
1601879	camphor 5 % / menthol 16 % / methyl salicylate 15 % Medicated Oil	SY	e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0	5
1601879	camphor 5 % / menthol 16 % / methyl salicylate 15 % Topical Oil	SY	e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0	5

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