FDA.reportPublic FDA data

Methyl Salicylate

Product NDC
50488-1015
11-digit product format
504881015
Labeler code
50488
Product ID
50488-1015_09e5a749-8ad0-42b8-a0cf-442474232d3f
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Alexso, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE250 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eef555d3-f23d-4847-93f3-fa7a06072a0fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1015-1Methyl Salicylate120 g in 1 BOTTLECREAM1204
50488-1015-5Methyl Salicylate50 g in 1 BOTTLECREAM504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1015-1GM - Gram50488-101534264966-05e1-41f6-882b-8d013f61a9fb12019-05-02
50488-1015-5GM - Gram50488-10154b60ebdd-351c-44ea-ab5b-19a2e6fa44b112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1015METHYL SALICYLATE CREAM [ALEXSO, INC]4Current NDC, Legacy NDC, 2 package rows20241208_eef555d3-f23d-4847-93f3-fa7a06072a0f.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 85 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMenper Distributors Inc.ad940dc8-9403-44cf-aed3-6e538cbe488b2025-07-22WarningsExact identifier
application number: M017
Balsamo de Vaca MascuraMETHYL SALICYLATEMenper Distributors Inc.321b6f1f-c802-4b96-99d3-e77217da11a32025-07-22WarningsExact identifier
application number: M017
Abejas y Viboras Roll OnMETHYL SALICYLATEMenper Distributors Inc.bedf3b36-7def-099f-e053-2a95a90ac15b2025-07-22WarningsExact identifier
application number: M017
HealthWise Flexible 4% Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3869cc18-5494-6142-e063-6394a90a75e52025-07-22WarningsExact identifier
application number: M017
Arthcal 4% Lidocaine PatchesLIDOCAINEBeijing JUNGE Technology Co., Ltd.2e531194-67ad-c645-e063-6394a90a916c2025-07-22WarningsExact identifier
application number: M017
AMRUTANJAN RELIEF STRONG PAIN BALMMENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITED206d8c1e-eb5b-4ec7-a54e-8defc9fb9d272025-07-22WarningsExact identifier
application number: M017
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
application number: M017
Mountain Ice Sports Pain ReliefMENTHOL, CAMPHORMountainside Medical Equipment, Inc.c1f5512c-67b1-4ff0-b1a5-616e883d436f2025-07-21WarningsExact identifier
application number: M017
Stopain Clinical Roll-OnMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.27703209-fdac-4620-a445-d89a84bc853d2025-07-21WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESTRATEGIC SOURCING SERVICES LLC9bac1869-8072-49bd-8568-a87a184d22002025-07-21WarningsExact identifier
application number: M017
Dr Kevin Khalili Pain Relief CreamMENTHOLDR. KHALILI LLC3a79b38c-9adc-60dd-e063-6394a90a5b302025-07-21WarningsExact identifier
application number: M017
ARTHRITIS PAIN RELIEFCAMPHOR, CAPSAICIN, METHYL SALICYLATEYUNNAN BAIYAO GROUP CO., LTD.671c57f0-3c6f-4416-bc81-f6930fef327b2025-07-21WarningsExact identifier
application number: M017
GoodSense Cooling Pain ReliefMENTHOLGeiss, Destin & Dunn, Inc2e5e1375-df07-9a43-e063-6394a90a99382025-07-20WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch CoolingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa7eae5dc-9db6-4bdf-9179-76060e75e0442025-07-18WarningsExact identifier
application number: M017
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
application number: M017
Aouiv 4% Lidocaine Numbing Cream4% LIDOCAINE NUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.3a221dd2-e945-bd0e-e063-6294a90a8fb92025-07-17WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
application number: M017
Hydrocortisone anti-itch plusHYDROCORTISONEWal-Mart Stores, Inc.a0c6e180-b385-4a9b-a9cf-84a551f533d02025-07-16WarningsExact identifier
application number: M017
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONESTRATEGIC SOURCING SERVICES LLCae4b7cd6-8b5d-4d25-86f9-72260638bb942025-07-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238542methyl salicylate 25 % Topical CreamPSNeef555d3-f23d-4847-93f3-fa7a06072a0f4
238542methyl salicylate 250 MG/ML Topical CreamSCDeef555d3-f23d-4847-93f3-fa7a06072a0f4
238542methyl salicylate 25 % Topical CreamSYeef555d3-f23d-4847-93f3-fa7a06072a0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-1015-150488101501120 g in 1 BOTTLE (50488-1015-1) 120 g2019-04-010000-00-00NoNoCurrent
50488-1015-55048810150550 g in 1 BOTTLE (50488-1015-5) 50 g2019-04-010000-00-00NoNoCurrent