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 89 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Patch	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	3875bde5-2e1a-5fdf-e063-6294a90a3c0d	2025-06-26	Warnings	Exact identifier application number: M017
SupreH Bee Venom Arthritis Pain Relieving Cream	SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3876cc44-7f3a-b084-e063-6294a90a6142	2025-06-26	Warnings	Exact identifier application number: M017
MediBalm	HYDROCORTISONE	BalmRx, LLC	324dd151-84c5-3e2f-e063-6394a90a569d	2025-06-26	Warnings	Exact identifier application number: M017
PHIZICO Pain Relief	MENTHOL	ER3 BRANDS INC.	72715dc5-d1e7-4b4b-8e28-4e367abba322	2025-06-25	Warnings	Exact identifier application number: M017
Diva Cramp Care Cream	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	37368566-b14e-4d5c-bdde-6eea9073974f	2025-06-25	Warnings	Exact identifier application number: M017
H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH	LIDOCAINE HCL	H2Ocean, LLC	386bf11b-1d71-44bf-e063-6394a90a2817	2025-06-25	Warnings	Exact identifier application number: M017
Burn Relief Extra Strength Kool-Down	LIDOCAINE - 3.9%	Kool-Down Inc	827fec2f-db3c-adbb-e053-2a91aa0a7c17	2025-06-25	Warnings	Exact identifier application number: M017
Hilook Blue Gel Anesthetic	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9db681-a297-5aa9-e063-6394a90a80ea	2025-06-25	Warnings	Exact identifier application number: M017
Hilook Numbing Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9f1a4c-ca0b-d820-e063-6394a90a3239	2025-06-25	Warnings	Exact identifier application number: M017
Lidocaine Knee Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	384c1ff8-80bd-86cb-e063-6394a90a2d65	2025-06-24	Warnings	Exact identifier application number: M017
Aroamas Cot Nicotine Transdermal Patches Kit	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	38576022-9413-c9af-e063-6294a90afd46	2025-06-24	Warnings	Exact identifier application number: M017
NERVE REVERSE PAIN RELIEF	MENTHOL	Pogue Medical Services	da97bcc6-5aa8-48e2-a2c2-c937745bf6d3	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief Menthol Roll-On	MENTHOL	Respect Manufacturing Corporation	05a6067a-287a-52d4-e063-6394a90a2c4e	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief 500mg Hemp Menthol Cream	MENTHOL	Respect Manufacturing Corporation	06c4640a-ee42-5d1a-e063-6394a90ad254	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief 1000mg Hemp Menthol Cream	MENTHOL	Respect Manufacturing Corporation	06e944e8-71f6-9fe9-e063-6294a90a8c37	2025-06-23	Warnings	Exact identifier application number: M017
Procure gel	MENTHOL	TWIN MED, LLC	e69c0b68-d408-9fd2-e053-2a95a90ac934	2025-06-20	Warnings	Exact identifier application number: M017
A Health Itch Relief Gel	ITCH RELIEF GEL	Bionpharma, Inc.	38040732-48c9-3533-e063-6394a90af10a	2025-06-20	Warnings	Exact identifier application number: M017
SCHOELIF Numbing Cream	NUMBING CREAM	Guangzhou Qiexiran Cosmetics Co., Ltd.	37eaabb7-884e-0bd5-e063-6294a90ae063	2025-06-19	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	37ee539c-df7e-511d-e063-6394a90a4469	2025-06-19	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	37eef80a-556f-b090-e063-6294a90a151b	2025-06-19	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