Methyl Salicylate 25 Percent

Product NDC
50488-1016
11-digit product format
504881016
Labeler code
50488
Product ID
50488-1016_78bef856-b769-49ad-89af-8e46966e99ec
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
2024-05-01
Substance
METHYL SALICYLATE
Active strength
250 mg/mL
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 Percent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE250 mg/mL

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
d8b8b0ba-69e9-4965-bf9b-6db21db69b34Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1016-5Methyl Salicylate 25 Percent50 mL in 1 BOTTLE, PUMPCREAM501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1016-5ML - Milliliter50488-1016bf43cf6a-cb28-4752-8ffa-6260e7ce719412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1016METHYL SALICYLATE 25 PERCENT (METHYL SALICYLATE) CREAM [ALEXSO, INC]1Current NDC, 1 package rows20240522_d8b8b0ba-69e9-4965-bf9b-6db21db69b34.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 113 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Cala Itch ReliefPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Rite Aide29a9d59-4c7c-81aa-e053-2995a90a70562024-12-15WarningsExact identifier
application number: M017
CVS Roll-OnCAPSAISIN 0.1%CVSe8812c49-335e-61ea-e053-2995a90a17aa2024-12-15WarningsExact identifier
application number: M017
Good Sense Burn Relief AloeLIDOCAINE HCLGeiss, Destin & Dunn, Incb5a7f629-a88d-b49d-e053-2995a90a49fa2024-12-15WarningsExact identifier
application number: M017
QC Burn Relief AloeLIDOCAINE HCLChain Drug Marketing Association Incb5e76f0c-0bfe-b13e-e053-2995a90a08612024-12-15WarningsExact identifier
application number: M017
Meijer Burn ReliefLIDOCAINE 0.5%Meijerbec60c93-5abd-ee04-e053-2a95a90acb612024-12-15WarningsExact identifier
application number: M017
QC Cool and Heat Roll-OnMENTHOL 16%Chain Drug Marketing Association Incd35e9dfa-8a28-fdb3-e053-2995a90abc522024-12-15WarningsExact identifier
application number: M017
Meijer Cold and Hot Pain RelievingMENTHOL 16%Meijerbec62df3-06c9-a115-e053-2995a90a42672024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain ReliefMENTHOL 16%Tommie Copper, Inc.b4dfa5fa-2d61-db1e-e053-2a95a90a7ac82024-12-15WarningsExact identifier
application number: M017
Pain Relief Liquid RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.c9f0447e-de43-16a5-e053-2995a90a05c12024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief Maximum StrengthTROLAMINE SALICYLATE 10%Tommie Copper, Inc.b622c14f-9bf3-0bbd-e053-2a95a90a2adc2024-12-15WarningsExact identifier
application number: M017
Copperlife Pain ReliefTROLAMINE SALICYLATE 10%Tommie Copper, Inc.c94d00f9-42ce-1d43-e053-2a95a90a058d2024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b6c3d6eb-b485-33b8-e053-2a95a90a41e12024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b4cd4fed-e8c8-db85-e053-2995a90a708b2024-12-15WarningsExact identifier
application number: M017
Copperlife Pain Relief LiquidMENTHOL 16%Tommie Copper, Inc.c93a0139-953b-5523-e053-2a95a90a0b2d2024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain ReliefTROLAMINE SALICYLATE 10%Tommie Copper, Inc.ca011b03-a263-1908-e053-2995a90ad9702024-12-15WarningsExact identifier
application number: M017
Warrior Chiggerex ReliefBENZOCAINE 10%Derma Care Research Labs, LLCdcf2f52b-2295-58e5-e053-2995a90a7fd82024-12-15WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLCdef8d341-06a7-0e9b-e053-2995a90a0ad62024-12-13WarningsExact identifier
application number: M017
Mentholatum OriginalCAMPHOR, MENTHOLThe Mentholatum Company19e4b812-67c6-49fd-833a-b432100363f52024-12-13WarningsExact identifier
application number: M017
Cold and Hot MedicatedMENTHOLThe Mentholatum Company85bf425d-59d7-4462-ba46-2921454600992024-12-13WarningsExact identifier
application number: M017
Mentholatum Lidocaine IceLIDOCAINE HCL, MENTHOLThe Mentholatum Company4d74cbab-31cd-4579-9360-6852ee215b5e2024-12-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238542methyl salicylate 25 % Topical CreamPSNd8b8b0ba-69e9-4965-bf9b-6db21db69b341
238542methyl salicylate 250 MG/ML Topical CreamSCDd8b8b0ba-69e9-4965-bf9b-6db21db69b341
238542methyl salicylate 25 % Topical CreamSYd8b8b0ba-69e9-4965-bf9b-6db21db69b341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50488-1016-55048810160550 mL in 1 BOTTLE, PUMP (50488-1016-5) 50 ml2024-05-01NoNoCurrent