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 93 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VBBV Tattoo NumbingLIDOCAINEJiashen International Trade Limited3557859e-f8b3-1049-e063-6394a90ad7372025-05-17WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company35415851-beba-5bb4-e063-6294a90a35c02025-05-16WarningsExact identifier
application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd352798e1-1e09-3d47-e063-6394a90ad4042025-05-15WarningsExact identifier
application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd35285d62-c660-a056-e063-6294a90aabc82025-05-15WarningsExact identifier
application number: M017
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company3508ae14-d9c9-3c85-e063-6294a90a00982025-05-13WarningsExact identifier
application number: M017
SORE NO MORE WARM THERAPYMENTHOL AND CAMPHORSOMBRA COSMETICS INC.cd86b56e-9b4c-4aca-9740-c8793cb120552025-05-12WarningsExact identifier
application number: M017
SORE NO MORE COOL THERAPYMENTHOLSOMBRA COSMETICS INC.9aa1f0ac-3baf-4e45-9e3a-c28a99b229092025-05-12WarningsExact identifier
application number: M017
Calm and Correct Serum with LidocaineLIDOCAINE 3 PERCENTRenu Laboratories, LLCddcf1c2e-2f67-44d7-e053-2a95a90a812b2025-05-09WarningsExact identifier
application number: M017
Mqupin Knee PatchKNEE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09772e4b-8193-3771-e063-6394a90a95162025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USAd57a59fb-c8f2-f73b-e053-2995a90a4cdb2025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA4c96ec41-841c-322b-e054-00144ff8d46c2025-05-08WarningsExact identifier
application number: M017
GNP Extra Strength Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEAmerisource Bergen34a66224-ef3c-e36e-e063-6394a90ac99d2025-05-08WarningsExact identifier
application number: M017
Good Neighbor Muscle Rub CreamCAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,Amerisource Bergen34924bb9-e3e8-70e6-e063-6294a90aaa8c2025-05-07WarningsExact identifier
application number: M017
DermaRad Relief Post Radiation CalmingLIDOCAINE 3 PERCENTRenu Laboratories, LLCe5d64929-fb9c-7ebc-e053-2995a90a93182025-05-07WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee0235-5a6e-0ea1-e063-6394a90a89a52025-05-06WarningsExact identifier
application number: M017
DermaRad ReliefLIDOCAINE EMULSIONRENU LABORATORIES, LLCd5e11f73-918b-eeac-e053-2995a90a4a832025-05-06WarningsExact identifier
application number: M017
Plantar Fasciitis Pain Relief Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd34838622-b092-afeb-e063-6294a90ae7db2025-05-06WarningsExact identifier
application number: M017
Climax Shield DelayBENZOCAINEPRODUCT MAX GROUP INC9c720cdc-f753-47ce-95ff-3b26e461a0ab2025-05-05WarningsExact identifier
application number: M017
PediFix Lidocaine Pain-Relief PatchesLIDOCAINE PAIN-RELIEF PATCHESPediFix, Inc346550b9-d2ba-184e-e063-6394a90a591a2025-05-05WarningsExact 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