Methyl Salicylate 25% Cream

Product NDC: 80425-0544
11-digit product format: 804250544
Labeler code: 80425
Product ID: 80425-0544_3bdd3021-d16d-12ea-e063-6394a90ab1e0
Type: HUMAN OTC DRUG
Nonproprietary name: Methyl Salicylate
Dosage form: CREAM
Route: CUTANEOUS
Labeler: Advanced Rx of Tennessee, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-08-08
Substance: METHYL SALICYLATE
Active strength: 250 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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 25% Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	250 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238542	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3bdd3015-349a-0fac-e063-6394a90afe41	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0544-1	Methyl Salicylate 25% Cream	120 g in 1 TUBE	CREAM	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0544-1	GM - Gram	80425-0544	a501e4a7-b11a-4bea-8338-523a961cfc7f	1	2025-09-12

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 131 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Poison Ivy Wash	PRAMOXINE HYDROCHLORIDE LOTION	Cardinal Health, 110 dba Leader	81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c	2024-05-13	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	0e808f89-62dc-3790-e063-6394a90a2351	2024-05-13	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Plus Cream	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Walgreens Company	e33e0097-31d6-8083-e053-2a95a90af5d2	2024-05-09	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold Gel	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1794c512-5f42-4ec3-e063-6394a90a87cd	2024-05-03	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro	MENTHOL AND CAMPHOR	ACTIVE AND INNOVATIVE, LLC	17961a84-6bee-c75f-e063-6394a90af576	2024-05-03	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Pain Relieving Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd	2024-05-01	Warnings	Exact identifier application number: M017
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Exact identifier application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 Bulk	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	17545078-05e1-9338-e063-6394a90a678c	2024-04-30	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Roll-on	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1755ec89-c404-1c17-e063-6394a90ab9fb	2024-04-30	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bc2a14-6bda-428c-e053-2995a90a4ced	2024-04-29	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Tube	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bec1d4-2e18-4519-e053-2a95a90a1bbb	2024-04-29	Warnings	Exact identifier application number: M017
THERAPLEX AIM Anti-Itch Moisturizing	HYDROCORTISONE	THERAPLEX, LLC	d1b231b6-cc9f-488a-9121-501831473772	2024-04-27	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE ACETATE	JHK Inc dba American Safety & First Aid	64adc8d0-7ca4-4c1a-813f-f1df47e916f2	2024-04-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Plus Cream	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	16f26249-b508-2c6e-e063-6394a90a265b	2024-04-25	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Cardinal Health 110 dba LEADER	16f2f3cb-4611-5867-e063-6394a90af107	2024-04-25	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	JHK Inc	5a4ac4cc-015a-48e7-81f8-93a895049afd	2024-04-25	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	ede15818-5d17-477d-a8be-7b36bb0770a6	2024-04-22	Warnings	Exact identifier application number: M017
Anti Itch	HYDROCORTISONE	Neilmed Pharmaceuticals Inc.	14b4f066-fde4-ac97-e063-6394a90ae64c	2024-04-20	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relief Patch	MENTHOL 5%	Walgreens Company	e33c90d1-2729-970f-e053-2995a90ad97a	2024-04-18	Warnings	Exact identifier application number: M017
HealthWise Cold Therapy Pain Relief Patch	MENTHOL	Veridian Healthcare	0ce356e0-90a3-ad52-e063-6294a90a404a	2024-04-18	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
238542	methyl salicylate 25 % Topical Cream	PSN	3bdd3015-349a-0fac-e063-6394a90afe41	1
238542	methyl salicylate 250 MG/ML Topical Cream	SCD	3bdd3015-349a-0fac-e063-6394a90afe41	1
238542	methyl salicylate 25 % Topical Cream	SY	3bdd3015-349a-0fac-e063-6394a90afe41	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0544-1	80425054401	120 g in 1 TUBE (80425-0544-1)	120 g	2025-08-08	No	No	Current