FDA.reportPublic FDA data

Methyl Salicylate 40 Percent

Product NDC
50488-6040
11-digit product format
504886040
Labeler code
50488
Product ID
50488-6040_0f2285bb-e726-497d-a690-b3ac543f98e7
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
2023-10-01
Substance
METHYL SALICYLATE
Active strength
400 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 40 Percent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE400 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
2668420Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53407aab-094c-4393-a2b9-54fd85321e3eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-6040-6Methyl Salicylate 40 Percent60 g in 1 BOTTLECREAM601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-6040-6GM - Gram50488-6040bc5f75f2-d697-48cd-9ab9-488b17615d6312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-6040METHYL SALICYLATE 40 PERCENT (METHYL SALICYLATE) CREAM [ALEXSO, INC]1Current NDC, 1 package rows20231030_53407aab-094c-4393-a2b9-54fd85321e3e.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 36 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Numbsure LIDOCAINELIDOCAINE 4%Hambli Limited43a65a12-ef2a-4608-e063-6394a90a82ea2026-01-31WarningsExact identifier
application number: M017
Collajoint Lidocaine Pain Relief Gel PatchLIDOCAINE PAIN RELIEF GEL PATCHHenan Enokon Medical Instrument Co., Ltd.44e27e7f-992f-d194-e063-6294a90a94e42026-01-31WarningsExact identifier
application number: M017
CAPSAICIN HEAT PatchCAPSAICIN HEAT PATCHHenan Enokon Medical Instrument Co., Ltd.49ac2045-2c07-af9a-e063-6294a90a052a2026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49ac6a7b-25d3-6dc4-e063-6394a90a99b62026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49aca763-be2a-cf38-e063-6294a90a092e2026-01-31WarningsExact identifier
application number: M017
PAIN RELIEF HOT PatchPAIN RELIEF HOT PATCHHenan Enokon Medical Instrument Co., Ltd.49ad128a-0f4c-085a-e063-6294a90ac9bb2026-01-31WarningsExact identifier
application number: M017
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company3557d2e9-714a-4066-aa73-ea9e3363e5742026-01-30WarningsExact identifier
application number: M017
Alveora HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4996f96a-898e-de01-e063-6394a90a39072026-01-30WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Rite Aid Corporationb67af0c7-1ae8-4494-bb0e-d7f66ebca3522026-01-30Warnings, Adverse reactionsExact identifier
application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITISCAPSAICINOL PHARMA TECH,LLC48fdf9dc-05df-866d-e063-6294a90ae03a2026-01-30WarningsExact identifier
application number: M017
ROCKTAPE GO Kinesiology Tape and AnalgesicMENTHOL, METHYL SALICYLATEImplus Footcare, LLCb779c7d8-dbe6-472f-9282-6cced25cfd2e2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLCde5f7add-1f2b-438a-ac17-753ebb53e6972026-01-29WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll-OnMENTHOL, METHYL SALICYLATEImplus Footcare, LLC5a2d9c3a-67fc-4c1a-b1e8-62a93880397a2026-01-29WarningsExact identifier
application number: M017
Analgesic Dr. ColladoMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.Ac0dad2db-7c96-49b8-a451-bf8cfa7f798b2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLC3121c7f7-d7e5-4ca9-9057-03edf9c94c562026-01-29WarningsExact identifier
application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl SalicylateMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.A.87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d2026-01-29WarningsExact identifier
application number: M017
ProCure Hydrocortisone Cream PlusHYDROCORTISONERooftop Consumer Health, Inc.fe334cae-e019-4397-8498-df3c923ae8b52026-01-29WarningsExact identifier
application number: M017
Red Oil Pain ReliefCAMPHOR (SYNTHETIC), MENTHOL, PHENOLThe Red Oil Company Inc1e36579a-72da-46ba-ac72-5960a11c08802026-01-29WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET POTENT PAIN RELIEF45c76956-db3f-3e84-e063-6394a90adce12026-01-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2668420methyl salicylate 40 % Topical CreamPSN53407aab-094c-4393-a2b9-54fd85321e3e1
2668420methyl salicylate 400 MG/ML Topical CreamSCD53407aab-094c-4393-a2b9-54fd85321e3e1
2668420methyl salicylate 40 % Topical CreamSY53407aab-094c-4393-a2b9-54fd85321e3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50488-6040-65048860400660 g in 1 BOTTLE (50488-6040-6) 60 g2023-10-01NoNoCurrent