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 81 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE	HYDROCORTISONE	Click Industries LLC	328c389c-7e05-4892-a9b3-b6a753f4935a	2025-08-25	Warnings	Exact identifier application number: M017
Yeheal	CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL	Shenzhen Yeheal Biotechnology Co., Ltd	3cf1bc74-3060-6d63-e063-6294a90a9f5c	2025-08-22	Warnings	Exact identifier application number: M017
Dermedial Anti-Ouch	MENTHOL	Natures Formulae Health Products Ltd.	3ce29160-3964-e435-e063-6394a90abb38	2025-08-21	Warnings	Exact identifier application number: M017
SUGARLOAF ORGANICS MENTHOL REVIVE	MENTHOL	RENU LABORATORIES, LLC	fa2f9539-b703-a00b-e053-6394a90ae309	2025-08-21	Warnings	Exact identifier application number: M017
Camphor 4% Plus Menthol 10%	CAMPHOR 4% PLUS MENTHOL 10%	PureTek Corporation	3cab26e4-e377-f26a-e063-6394a90a17af	2025-08-20	Warnings	Exact identifier application number: M017
Capsaicin 0.035% Cream	CAPSAICIN 0.035% CREAM	Puretekcorp	3cbc73b6-8c58-8f23-e063-6394a90a71a3	2025-08-20	Warnings	Exact identifier application number: M017
Game On	MENTHOL, METHYL SALICYLATE	Natural Essentials, Inc.	3cd20f1f-033f-f698-e063-6294a90a89eb	2025-08-20	Warnings	Exact identifier application number: M017
ELAIMEI Numbing Cream	LIDOCAINE 4%	Shenzhen Shandian Jingling Technology Co., Ltd.	37ac13b2-ca55-0e28-e063-6294a90a000e	2025-08-19	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	FSA Store Inc.	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	2025-08-19	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE SPRAY	FSA Store Inc.	3ce24b87-55ac-0bbd-e063-6294a90ab582	2025-08-19	Warnings	Exact identifier application number: M017
Fast Freeze Pain Relieving	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	15a26af1-ca5a-40fc-a411-6c0e8ae18fbb	2025-08-18	Warnings	Exact identifier application number: M017
Orythia Maximum Strength Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	6d6b59f9-f614-4e3c-b07b-32b4591d39f2	2025-08-18	Warnings	Exact identifier application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving Soothing	LIDOCAINE	GNL BRANDS INTERNATIONAL, LLC	3c69654c-cba6-dfef-e063-6394a90ad479	2025-08-15	Warnings	Exact identifier application number: M017
Earth Mama Medicated Herbal Lip Balm	MENTHOL	Eleeo Brands LLC	3c6c16bb-1f4b-b851-e063-6294a90a7404	2025-08-15	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cintas First Aid & Safety	96f17095-31f3-4b8a-ab22-0caaefaa7476	2025-08-15	Warnings	Exact identifier application number: M017
MedPride Cold Ice Analgesic Gel	MENTHOL	SHIELD LINE LLC	860a2c86-b240-4e0e-e053-2a91aa0a333a	2025-08-15	Warnings	Exact identifier application number: M017
MedPride Medicated Body Powder Powder	MENTHOL, ZINC OXIDE	Shield Line LLC	cdb2fa5b-cf04-c876-e053-2a95a90a187c	2025-08-15	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE	HART Health	c5ff392a-e788-43e0-91ea-5e0f8420586c	2025-08-15	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	40df30ba-41ba-42b7-93fe-4183b57bdb00	2025-08-14	Warnings	Exact identifier application number: M017
Signature Care Aloe Vera Gel with Lidocaine	LIDOCAINE	Safeway, Inc.	d5069622-97b1-ba12-e053-2a95a90a7268	2025-08-14	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