Methyl Salicylate

Product NDC: 79643-009
Requested package NDC: 79643-009-01
11-digit product format: 796430009
Labeler code: 79643
Product ID: 79643-009_5d6e9259-0510-5f9f-e063-6394a90a4845
Type: HUMAN OTC DRUG
Nonproprietary name: Methyl Salicylate
Dosage form: CREAM
Route: TOPICAL
Labeler: PHARMACURE LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-02-01
Substance: METHYL SALICYLATE
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Methyl Salicylate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	100 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79643-009-01	Methyl Salicylate	1 in 1 BOX	CREAM	1		1
79643-009-01	Methyl Salicylate	100 g in 1 TUBE	CREAM	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79643-009	METHYL SALICYLATE CREAM [PHARMACURE LLC]	1	Current NDC, 2 package rows	20250207_8803ae01-ea48-46c2-ab64-bb273de605ac.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 145 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INTIMALE Maximum Strength Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25b9ade3-72b0-4b86-8c48-90310a26806f	2023-11-11	Warnings	Exact identifier application number: M017
POWERECT Max Power Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25a1c926-9543-44a7-865e-a4b6e1a40cbe	2023-11-11	Warnings	Exact identifier application number: M017
SKINS DELAY Maximum Strength Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	172efe5d-28b8-443c-b3f9-429669189081	2023-11-11	Warnings	Exact identifier application number: M017
GASPARI Ageless Pain Relief Cream	MENTHOL	GASPARI ANTI-AGING LLC	ea806089-688b-4944-ad69-86f366509eb5	2023-11-11	Warnings	Exact identifier application number: M017
ZENSEZONE Arthmed Temporary Pain Relief Cream	CAPSAICIN, MENTHOL, METHYL SALICYLATE	ZENSEZONE LLC	c5778f22-c411-4bd7-b2af-45e3fee15fd2	2023-11-11	Warnings	Exact identifier application number: M017
PRFC HEMP Topical Analgesic	MENTHOL	DOBEST INC	722da9d1-91d7-45be-adb1-8d6a22aa83ac	2023-11-11	Warnings	Exact identifier application number: M017
AMP RELIEF Pain Relief Cream	MENTHOL	COASTAL FORMULAS LLC	84ea496e-ab54-4882-93ef-600f8eb33cb4	2023-11-11	Warnings	Exact identifier application number: M017
AMP RELIEF Pain Relief Cream	MENTHOL	COASTAL FORMULAS LLC	39564c67-49ab-42d4-a391-792ac69180c0	2023-11-11	Warnings	Exact identifier application number: M017
LIDOSOLVE PAIN RELIEF	LIDOCAINE HYDROCHLORIDE	HENNIKA HEALTH, LLC	3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2	2023-11-11	Warnings	Exact identifier application number: M017
AMINO ACTIVE Topical Analgesic Cream	HISTAMINE DIHYDROCHLORIDE	VIREO SYSTEMS, INC.	591b1e7e-a8c0-4640-a592-4e0f3538a40e	2023-11-11	Warnings	Exact identifier application number: M017
NERVE ACTIVE Pain Relief Cream	MENTHOL	TOP DOG DIRECT, LLC	a8b85dcb-fd3e-4340-a945-609fc741443c	2023-11-11	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back	LIDOCAINE	Geri-Gentle Corporation	e4427928-c063-9ca6-e053-2995a90a1aa1	2023-11-10	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and Neck	MENTHOL	Geri-Gentle Corporation	e4429f70-667e-662b-e053-2a95a90a62ba	2023-11-10	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch Back	MENTHOL	Geri-Gentle Corporation	e442b8ec-a3de-65e8-e053-2995a90af3ec	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	9f948fb4-4275-4a1f-83f8-cd708db4a296	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF PAIN RELIEF	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	b4278b70-e9a6-4d1f-bbad-257fe437b86a	2023-11-10	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain Relief	MENTHOL, CAPSAICIN	BLUE SPRING WELLNESS, L.L.C.	2f9cf514-48be-49ec-b424-0b228b4b874a	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	1231ddd2-7661-45b2-ab15-32f7fdc078a8	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE Stuff Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	7779b26b-ae3b-4639-a6b0-826c7ab37a86	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4	2023-11-10	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311635	methyl salicylate 10 % Topical Cream	PSN	8803ae01-ea48-46c2-ab64-bb273de605ac	1
311635	methyl salicylate 100 MG/ML Topical Cream	SCD	8803ae01-ea48-46c2-ab64-bb273de605ac	1
311635	methyl salicylate 10 % Topical Cream	SY	8803ae01-ea48-46c2-ab64-bb273de605ac	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
79643-009-01	79643000901	1 TUBE in 1 BOX (79643-009-01) / 100 g in 1 TUBE	1 tube	2025-02-01	No	No	Current