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 120 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Acme United Corporation	f1f051ad-7e82-9d1a-e053-2a95a90ac7d3	2024-11-12	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	ALLIED TRADE LINK LLC	26bc238d-3bda-0c29-e063-6394a90a35fb	2024-11-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Acme United Corporation	fabcaa3b-d189-bd29-e053-6294a90ae86b	2024-11-12	Warnings	Exact identifier application number: M017
ActivICE	MENTHOL	Medline Industries, LP	8414aea2-52b5-4221-e053-2a91aa0a622e	2024-11-12	Warnings	Exact identifier application number: M017
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	26c7116f-c86d-8752-e063-6294a90ab73f	2024-11-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Kroger Company	fc1677f2-4078-4ebd-9c3b-86a29a35b489	2024-11-12	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Cream	LIDOCAINE	CVS Health	ad950680-c03c-4fa5-aa7f-239a889cd097	2024-11-12	Warnings	Exact identifier application number: M017
CVS Arthritis Pain Relief	ARTHRITIS PAIN RELIEF	CVS Health	575dd514-fd99-4e44-8fc8-52938f9abc26	2024-11-11	Warnings	Exact identifier application number: M017
ThermaPatch (TM) Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	26769590-cd50-1b01-e063-6394a90a445c	2024-11-09	Warnings	Exact identifier application number: M017
DG Health Cold Zone Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Dolgencorp Inc	22594ab8-9a4a-426f-aced-5c636620fa2c	2024-11-08	Warnings	Exact identifier application number: M017
Peviderm Pramoxine Hydrocholride 1%	PRAMOXINE HYDROCHLORIDE	Stratus Pharmaceuticals Inc	680b40fa-1922-443a-a4b0-7c3f6a2b847d	2024-11-07	Warnings	Exact identifier application number: M017
Meijer Analgesic with Aloe Topical Analgesic	TROLAMINE SALICYLATE	Meijer Distribution, Inc	f6c1e09e-4c61-4c2a-87d7-b052ed36fcac	2024-11-07	Warnings	Exact identifier application number: M017
Meijer Pain Relieving Balm Analgesic	TROLAMINE SALICYLATE	Meijer Distribution, Inc	1b7535cc-01ac-49f0-9889-dd14b254d4ae	2024-11-07	Warnings	Exact identifier application number: M017
BENGAY Tropical Jasmine	LIDOCAINE	Kenvue Brands LLC	c416320a-c0d7-401e-b0fa-44114d76a557	2024-11-06	Warnings	Exact identifier application number: M017
Bengay Ultra Strength Large Size	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	f57ccc33-400b-4401-a348-c54d1eb9f5d0	2024-11-06	Warnings	Exact identifier application number: M017
Band Aid Antiseptic Cleansing To Go	BENZALKONIUM CHLORIDE, PRAMOXINE HCL	Kenvue Brands LLC	d5749cba-32f3-cf9c-e053-2a95a90a4416	2024-11-06	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	GOLDEN TIGER DISTRIBUTION L.L.C.	26473383-282c-fb10-e063-6394a90a5fa2	2024-11-06	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	GOLDEN TIGER DISTRIBUTION L.L.C.	1b6f929a-db65-8a02-e063-6394a90a8b59	2024-11-06	Warnings	Exact identifier application number: M017
Meijer Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	bd6f04f9-a23b-45f6-bce2-1ef7203198e1	2024-11-06	Warnings	Exact identifier application number: M017
Meijer Cold and Hot Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	6d356563-9098-4994-8ad8-819a8033a9f4	2024-11-06	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