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 122 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sanar Naturals Arnica Reforzada	CAMPHOR	Sanvall Enterprises, Inc	1921a4b1-cd36-195e-e063-6294a90a8793	2024-10-31	Warnings	Exact identifier application number: M017
Sanar Naturals Arnica Pain Releiving Roll On with Camphor	CAMPHOR	Sanvall Enterprises, Inc	173db0e2-611f-55b9-e063-6394a90ac987	2024-10-31	Warnings	Exact identifier application number: M017
Sanar Naturals Camphor	CAMPHOR	Sanvall Enterprises, Inc	1921e851-cf83-0bdb-e063-6294a90a357f	2024-10-31	Warnings	Exact identifier application number: M017
cortisone	HYDROCORTISONE	CVS Pharmacy	c766deac-d993-4e48-a5c3-4cfde7338dff	2024-10-31	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving with Lavender Analgesic	LIDOCAINE HYDROCHLORIDE	Walgreen Company	6c7b39c8-5b65-430a-a529-5b6b14adce18	2024-10-31	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Plus Turmeric Analgesic	TROLAMINE SALICYLATE	Walgreen Company	f3a121bc-7572-49a4-9822-2b6d858c19d2	2024-10-31	Warnings	Exact identifier application number: M017
dg health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	27dc9e09-fc4f-4b66-a303-177725f3a513	2024-10-31	Warnings	Exact identifier application number: M017
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	f5419859-3f9f-43ff-9a3f-6aa81af044f0	2024-10-31	Warnings	Exact identifier application number: M017
ARCTIC RELIEF	MENTHOL, UNSPECIFIED FORM	STRATUS PHARMACEUTICALS INC	d27fbc17-46b7-4d52-ba29-c99b6c63144a	2024-10-31	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE, MENTHOL	R & Y Group, LLC	fe0478d8-2f06-cd56-e053-6294a90a58e5	2024-10-30	Warnings	Exact identifier application number: M017
JOINT-RITIS PAIN RELIEVING ROLL-ON	MENTHOL	Lifeline Naturals of America, Inc.	ec5d99c4-6bba-45d1-84e0-12fb7cb31495	2024-10-30	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving with Turmeric Analgesic	LIDOCAINE HYDROCHLORIDE	Walgreen Company	317ec4fb-cff0-461d-9ca0-299527a3686d	2024-10-30	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Walgreen Company	3215a676-104c-43c3-aa36-b30d5b67799a	2024-10-30	Warnings	Exact identifier application number: M017
Ultra-Strength Pain Relief Analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	TARGET CORPORATION	159c5a84-bf68-41dd-a2d3-bc2402037244	2024-10-30	Warnings	Exact identifier application number: M017
DG Health Cold n Hot Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Dolgencorp Inc	8fe13b85-ab74-42f8-a664-d3d2959921ac	2024-10-30	Warnings	Exact identifier application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	8ba42864-69bf-455c-98d4-7f4ff94edceb	2024-10-29	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	beefab66-b056-4bf1-b047-0780704ab87e	2024-10-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	H E B	15eb4676-5f6e-4c28-b5b9-4e45412dc37a	2024-10-29	Warnings	Exact identifier application number: M017
Rael PAIN RELIEF ROLL-ON Analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Rael, Inc.	e6c49606-7c13-4dc6-a22d-ba54173ba788	2024-10-28	Warnings	Exact identifier application number: M017
Monistat Care Instant Itch Relief	BENZOCAINE	Insight Pharmaceuticals LLC	4e9dc791-419f-4c79-aed4-760f8c17a5dd	2024-10-25	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