FDA.reportPublic FDA data

Methyl Salicylate

Product NDC
50488-2010
11-digit product format
504882010
Labeler code
50488
Product ID
50488-2010_e7bb5525-446b-42ae-b4cd-c3c25a2521ec
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Alexso, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-11
Substance
METHYL SALICYLATE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methyl Salicylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 g/100g

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
1053397Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bac67f94-8627-47ff-a736-37feab77330aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-2010-1Methyl Salicylate2 in 1 BOXPATCH22
50488-2010-1Methyl Salicylate5 in 1 POUCHPATCH52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-2010-1EA - Each50488-201029923153-67b9-43b6-a527-3585fb9a7b2512021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-2010METHYL SALICYLATE PATCH [ALEXSO, INC]2Current NDC, Legacy NDC, 2 package rows20241208_bac67f94-8627-47ff-a736-37feab77330a.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATEAlexso, Incbac67f94-8627-47ff-a736-37feab77330a2024-12-09WarningsExact identifier
ndc (product): 50488-2010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053397methyl salicylate 10 % Medicated PatchPSNbac67f94-8627-47ff-a736-37feab77330a2
1053397methyl salicylate 0.1 MG/MG Medicated PatchSCDbac67f94-8627-47ff-a736-37feab77330a2
1053397methyl salicylate 10 % Medicated PatchSYbac67f94-8627-47ff-a736-37feab77330a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-2010-1504882010012 POUCH in 1 BOX (50488-2010-1) / 5 PATCH in 1 POUCH / 100 g in 1 PATCH2 pouch2021-02-110000-00-00NoNoCurrent