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 59 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thera Plus Maximum Strength Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc	7d4e21d1-2914-4690-9084-a52abeab0958	2025-12-02	Warnings	Exact identifier application number: M017
Rugby Capsaicin Cream	CAPSAICIN	Rugby Laboratories	9eca34f1-e91a-3ac1-e053-2a95a90a9bd9	2025-12-02	Warnings	Exact identifier application number: M017
Leader Capsaicin Pain Relief Cream	CAPSAICIN	Cardinal Health 110 dba LEADER	a5620709-0fed-4979-e053-2a95a90ac654	2025-12-02	Warnings	Exact identifier application number: M017
Hydrocortisone Acetate Antipruritic (Anti-Itch)	HYDROCORTISONE ACETATE	Sun Pharmaceutical Industries, Inc.	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	2025-12-02	Warnings	Exact identifier application number: M017
POMG NIGHT TIME PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE	POMG LLC	28d7dfb0-a94c-90de-e063-6294a90a036a	2025-12-02	Warnings	Exact identifier application number: M017
Thermacare Max Strength Lidocaine	THERMACARE MAX STRENGTH LIDOCAINE	Clarion Brands LLC	44fed887-d1e0-d205-e063-6294a90ac416	2025-12-02	Warnings	Exact identifier application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ON	MENTHOL	SUNSET NOVELTIES, INC	45037bc1-aa03-11ae-e063-6294a90a6c96	2025-12-02	Warnings	Exact identifier application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ON	CAMPHOR	SUNSET NOVELTIES, INC	45048936-f3c9-25f7-e063-6394a90ac4a9	2025-12-02	Warnings	Exact identifier application number: M017
CAREALL Anti-Itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM	New World Imports, Inc	3a01f57a-ebc6-4724-b625-1d1ea4b85e73	2025-12-01	Warnings	Exact identifier application number: M017
CareALL Arthritis and Muscle	CAPSAICIN	New World Imports, Inc	4867eac4-00ea-434e-b289-1c1ef0342c23	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	e2df8130-e7c8-4fde-a6d6-c71378991213	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	d04e473d-8bbc-475c-a0b1-ca5eed67fbc7	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Muscle Rub Ultra Strength	MENTHOL, METHYL SALICYLATE	New World Imports, Inc	cba7c084-379f-4a16-aeba-b11ca6e20d8a	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Muscle Rub Ultra Strength	MENTHOL, METHYL SALICYLATE	New World Imports, Inc	d066002d-8ceb-4d16-9744-d5ca25d2ad5a	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Musle and Joint	MENTHOL	New World Imports, Inc	013beea4-b2c2-4e84-b4cb-3125ac48e8c0	2025-12-01	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	A2A Integrated Pharmaceuticals, LLC	147f3594-7362-7a78-e063-6294a90a3e42	2025-11-30	Warnings	Exact identifier application number: M017
Aquanil HC	HYDROCORTISONE	Person and Covey	6b9258e4-c7c4-765e-e053-2991aa0a9f4e	2025-11-29	Warnings	Exact identifier application number: M017
Walgreen Pain Relieving Fragrance Free	LIDOCAINE HYDROCHLORIDE	WALGREENS CO.	62c50ded-3fc9-4f65-9bfb-1144ed2e36b4	2025-11-26	Warnings	Exact identifier application number: M017
Itch Relief	ITCH RELIEF GEL	Neilmed Pharmaceuticals Inc.	44811828-c32e-17fc-e063-6294a90add48	2025-11-26	Warnings	Exact identifier application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon	THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON	Clarion Brands LLC	4482d34d-eaca-5522-e063-6394a90a6afb	2025-11-26	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