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 113 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Cala Itch Relief	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Rite Aid	e29a9d59-4c7c-81aa-e053-2995a90a7056	2024-12-15	Warnings	Exact identifier application number: M017
CVS Roll-On	CAPSAISIN 0.1%	CVS	e8812c49-335e-61ea-e053-2995a90a17aa	2024-12-15	Warnings	Exact identifier application number: M017
Good Sense Burn Relief Aloe	LIDOCAINE HCL	Geiss, Destin & Dunn, Inc	b5a7f629-a88d-b49d-e053-2995a90a49fa	2024-12-15	Warnings	Exact identifier application number: M017
QC Burn Relief Aloe	LIDOCAINE HCL	Chain Drug Marketing Association Inc	b5e76f0c-0bfe-b13e-e053-2995a90a0861	2024-12-15	Warnings	Exact identifier application number: M017
Meijer Burn Relief	LIDOCAINE 0.5%	Meijer	bec60c93-5abd-ee04-e053-2a95a90acb61	2024-12-15	Warnings	Exact identifier application number: M017
QC Cool and Heat Roll-On	MENTHOL 16%	Chain Drug Marketing Association Inc	d35e9dfa-8a28-fdb3-e053-2995a90abc52	2024-12-15	Warnings	Exact identifier application number: M017
Meijer Cold and Hot Pain Relieving	MENTHOL 16%	Meijer	bec62df3-06c9-a115-e053-2995a90a4267	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief	MENTHOL 16%	Tommie Copper, Inc.	b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8	2024-12-15	Warnings	Exact identifier application number: M017
Pain Relief Liquid Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	c9f0447e-de43-16a5-e053-2995a90a05c1	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Maximum Strength	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	b622c14f-9bf3-0bbd-e053-2a95a90a2adc	2024-12-15	Warnings	Exact identifier application number: M017
Copperlife Pain Relief	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	c94d00f9-42ce-1d43-e053-2a95a90a058d	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	b6c3d6eb-b485-33b8-e053-2a95a90a41e1	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	b4cd4fed-e8c8-db85-e053-2995a90a708b	2024-12-15	Warnings	Exact identifier application number: M017
Copperlife Pain Relief Liquid	MENTHOL 16%	Tommie Copper, Inc.	c93a0139-953b-5523-e053-2a95a90a0b2d	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	ca011b03-a263-1908-e053-2995a90ad970	2024-12-15	Warnings	Exact identifier application number: M017
Warrior Chiggerex Relief	BENZOCAINE 10%	Derma Care Research Labs, LLC	dcf2f52b-2295-58e5-e053-2995a90a7fd8	2024-12-15	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	def8d341-06a7-0e9b-e053-2995a90a0ad6	2024-12-13	Warnings	Exact identifier application number: M017
Mentholatum Original	CAMPHOR, MENTHOL	The Mentholatum Company	19e4b812-67c6-49fd-833a-b432100363f5	2024-12-13	Warnings	Exact identifier application number: M017
Cold and Hot Medicated	MENTHOL	The Mentholatum Company	85bf425d-59d7-4462-ba46-292145460099	2024-12-13	Warnings	Exact identifier application number: M017
Mentholatum Lidocaine Ice	LIDOCAINE HCL, MENTHOL	The Mentholatum Company	4d74cbab-31cd-4579-9360-6852ee215b5e	2024-12-13	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