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 80 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelievingMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY27679d31-a5f3-417b-b0c5-5f6b001ecff92025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM52fff03e-eba2-4604-a71c-2522468f627b2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde210c3a-c24e-cefd-e053-2a95a90a93ff2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY799751f3-726a-42de-934e-dbc3cd1cb8b82025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde0c9a73-dbc0-599e-e053-2a95a90a79862025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM90334420-5f81-4284-9a57-42e134ce362f2025-09-02WarningsExact identifier
application number: M017
KNEE PAIN RELIRF PatchCAMPHOR, MENTHOLShenzhen Finona Information Technology Co., Ltd3db971ef-d7fa-0171-e063-6294a90aa58b2025-09-01WarningsExact identifier
application number: M017
Bikini Zone Medicated CremeLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC300ac57e-844a-4840-b285-41ff5518e6b62025-08-29WarningsExact identifier
application number: M017
Bikini Zone Medicated GelLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC30b85890-e72d-4af7-bda9-e7744abc92af2025-08-29WarningsExact identifier
application number: M017
Sumifun Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3d7dc8cc-0680-d94d-e063-6394a90ac8e82025-08-29WarningsExact identifier
application number: M017
TKTALKER NUMBINGNUMBINGShenzhen Shandian Jingling Technology Co., Ltd.3d7e6757-f183-2a68-e063-6294a90ae4ca2025-08-29WarningsExact identifier
application number: M017
PBZ OTCTRIPELENNAMINE HCL 1%Kingsway Pharmaceuticals dba NFI, LLC12f72d74-018f-4bc6-acd4-175ca3af4c6d2025-08-29WarningsExact identifier
application number: M017
else.LIDOCAINEElse Co.3d6c7b10-ed03-bbde-e063-6294a90ae92f2025-08-28WarningsExact identifier
application number: M017
Mountain Ice Pain ReliefMENTHOLMountainside Medical Equipment, Inc.c79fdd91-16f4-4ae0-bee4-d37c05ed20742025-08-28WarningsExact identifier
application number: M017
HealthWise 4% Lidocaine Cream 2.7 ozLIDOCAINE HYDROCHLORIDEVeridian Healthcaref39eb3d0-e153-4f50-85b1-ad5c677d176c2025-08-28WarningsExact identifier
application number: M017
HealthWise Overnight Menthol PatchMENTHOLVeridian Healthcare6379f50d-2878-46ca-8acb-71c4554585e92025-08-28WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLC119bab58-f129-4ff0-8d81-9c6a7b508dd62025-08-28WarningsExact identifier
application number: M017
Anti Itch Maximum ReliefPRAMOXINE HYDROCHLORIDE AND MENTHOLNatureplex LLC75de3d5e-ecbe-4d04-a39d-792200e6ee322025-08-28WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.3d5718f3-c175-6b64-e063-6394a90aa6f12025-08-27WarningsExact identifier
application number: M017
ARCTIC HEATMENTHOL, METHYL SALICYLATERenu Laboratories, LLC402df5c1-b8cb-17a2-e054-00144ff8d46c2025-08-27WarningsExact 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