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 137 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
application number: M017
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
application number: M017
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
application number: M017
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact identifier
application number: M017
Leader Burn ReliefLIDOCAINECardinal Healthf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22024-02-06WarningsExact identifier
application number: M017
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
application number: M017
White CreamCAMPHOR (NATURAL) AND TURPENTINE OILJ.R. Watkins, LLC.e4de0734-59d5-478c-86ea-66fc2ba003e72024-02-05WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.80118260-9c88-402d-9a90-ecfe62b4b54f2024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.df512ce6-ce1b-434d-9571-fb2e1d76e1d02024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOLSafetec of America, Inc.52ebf64d-095f-467e-bf51-dd8d33b58c7d2024-02-05WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDESafetec of America, Inc.4f4c801b-d894-4fa3-b024-6ca41a5f2a952024-02-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.79e3b0e7-4ba5-4b9d-a980-5b6f18dba8022024-02-04WarningsExact identifier
application number: M017
HAV EZ Penetrating Pain ReliefMENTHOLPALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC70006efc-9cc8-4490-b28c-fcb23b1737c42024-02-01WarningsExact identifier
application number: M017
Rugby Capsaicin External AnalgesicCAPSAICINProficient Rx LP7c733a30-5002-49e7-a6bd-7737a1d2461e2024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPccb62898-b614-45b9-95ea-23e5e31893a82024-02-01WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEProficient Rx LP0b26d92f-9d0e-46d4-a8bc-75d6da5f61992024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPc57d5f8e-5934-4cbb-999a-cdd55e5b105f2024-02-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEProficient Rx LP47e9fe84-bd0c-40ea-85de-e950bcacc5572024-02-01WarningsExact 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