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 98 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	3a36a241-37a9-445a-a6e0-97709a7457a8	2025-03-19	Warnings	Exact identifier application number: M017
Herb Analgesic	HERB ANALGESIC PASTE	Changsha Maocheng Trading Co., Ltd	29373587-9eff-6ea0-e063-6394a90a23b2	2025-03-18	Warnings	Exact identifier application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	f469b446-58a0-4be3-884f-d622b9d074f8	2025-03-17	Warnings	Exact identifier application number: M017
Auvon 4% Menthol Pain Relief Gel	MENTHOL	SHENZHEN YUWEN E-COMMERCE CO., LTD.	2dacd6fe-7d69-bcf0-e063-6294a90a0351	2025-03-14	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	1ee49cad-84d4-42cf-aa83-c0da6f1b1b84	2025-03-14	Warnings	Exact identifier application number: M017
AY BENDITO THERMOACTIVE	MENTHOL, CAMPHOR	AY BENDITO INTERNATIONAL, INC	304d71b6-91c8-b2b6-e063-6394a90ab669	2025-03-14	Warnings	Exact identifier application number: M017
Hot/Cold Medicated Patch	HOT COLD PATCH	Dynarex	999881b3-287e-d975-e053-2995a90a87e3	2025-03-14	Warnings	Exact identifier application number: M017
Capsaicin 0.025%	CAPSAICIN 0.025%	Marcella Health	3054e7fd-cab2-7f77-e063-6294a90a498d	2025-03-14	Warnings	Exact identifier application number: M017
MENTHOL 5%	MENTHOL 5%	Marcella Health	30914c0a-fbda-5674-e063-6294a90aba5b	2025-03-14	Warnings	Exact identifier application number: M017
Peppermint Soothing Patch	CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM	Henan Lijitang Medical Technology Co., Ltd.	30361dd4-1f3d-ac5e-e063-6294a90a23bc	2025-03-13	Warnings	Exact identifier application number: M017
AVCOO Menthol Pain Relief Patch	MENTHOL	ADP Health Limited	3036804b-16c3-0c88-e063-6394a90a3084	2025-03-13	Warnings	Exact identifier application number: M017
LIDOCAINE 4%	LIDOCAINE 4%	Marcella Health	303d9462-cbfb-6251-e063-6394a90a7065	2025-03-13	Warnings	Exact identifier application number: M017
XeroBurn Burn Gel	LIDOCAINE HYDROCHLORIDE	Dynarex Corporation	58985046-ca9c-12be-e053-2991aa0abe72	2025-03-13	Warnings	Exact identifier application number: M017
Post Treatment Repair Cream	HYDROCORTISONE	Vege Labs LLC.	302d4327-354b-a252-e063-6394a90a20b6	2025-03-12	Warnings	Exact identifier application number: M017
TheraCare Pain Relief 4% Lidocaine	LIDOCAINE	Veridian Healthcare	2d3fc030-5d53-2acd-e063-6294a90a11ab	2025-03-11	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Veridian Healthcare	2d413707-794c-2fa8-e063-6394a90a06bf	2025-03-11	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Veridian Healthcare	2d04799f-946d-ac53-e063-6294a90afeb7	2025-03-11	Warnings	Exact identifier application number: M017
Muscle and Joint Care	LIDOCAINE	Vege Labs LLC.	301966b5-b535-dc04-e063-6394a90aec17	2025-03-11	Warnings	Exact identifier application number: M017
Arctic Blast Pain Releiving	MENTHOL, CAMPHOR (SYNTHETIC)	Nutriomo Labs Pte, Ltd	d5e7d26d-4f63-4b7b-a173-fe3a794c8459	2025-03-10	Warnings	Exact identifier application number: M017
Anti Itch	WALGREEN	Walgreens	30014ff0-2519-4031-e063-6394a90ae07b	2025-03-10	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