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 96 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NOVUM APR	MENTHOL	NOVUM SOLUTIONS INC	1b869a1f-5787-4d03-a546-43a8217b2b2c	2025-04-07	Warnings	Exact identifier application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLING	MENTHOL	RENU LABORATORIES, LLC	31e4fa2c-3a98-d618-e063-6394a90aec1c	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	cc7cbf4a-8274-e463-e053-2995a90a51e0	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee018a-2c3c-3116-e053-2a95a90ac8d8	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee2b65-2759-0e62-e053-2a95a90a0378	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bdc7c7f3-ac98-8fe9-e053-2a95a90a2663	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bd4fdff1-9174-31c2-e053-2a95a90a749f	2025-04-07	Warnings	Exact identifier application number: M017
GREEN GUARD Topical Pain Relief	LIDOCAINE HCI	Ultra Distributors Inc	b6f0041c-47fc-0bcd-e053-2a95a90ab1f9	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebc1c6-93fb-efd6-e053-2995a90a25bb	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 4	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0e9ac7c-a840-2e05-e053-2a95a90a33f1	2025-04-07	Warnings	Exact identifier application number: M017
CBDMEDIC Active Sport Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec5f47-2f8e-0558-e053-2a95a90aa7ca	2025-04-07	Warnings	Exact identifier application number: M017
Hot Cold Medicated Patches	HOT COLD MEDICATED PATCHES	Henan Enokon Medical Instrument Co., Ltd.	159266a8-94fa-e2ff-e063-6394a90a9a77	2025-04-02	Warnings	Exact identifier application number: M017
Pain Relief Patch	PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592d29d-e275-a44d-e063-6294a90ab17d	2025-04-02	Warnings	Exact identifier application number: M017
Jointflex	CAMPHOR	Strides Consumer LLC	766b73f2-67bd-4d5c-805c-1057b3981ebf	2025-04-02	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Asclemed USA, Inc.	d4d556c1-b64b-4b8e-8e4b-4f40eda24250	2025-04-01	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	31ce185e-07b7-d837-e063-6394a90a1fb0	2025-04-01	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL 10.5%	CVS	d0ea80ce-38b2-acde-e053-2995a90a47e5	2025-03-31	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	A2A Integrated Pharmaceuticals, LLC	31431866-6fb5-2acd-e063-6294a90ac520	2025-03-31	Warnings	Exact identifier application number: M017
Citrus Cleansing Foot Soak and Body Soak	CAMPHOR	SANSAR, LLC	f136616d-9f32-4e55-a495-b7466fd68526	2025-03-28	Warnings	Exact identifier application number: M017
Zpol ULTRA	MENTHOL, METHYL SALICYLATE	Laboratorios Zepol S.A.	1a1433a6-8d04-96df-e063-6394a90a987b	2025-03-27	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