FDA.reportPublic FDA data

Methyl Salicylate

Product NDC
84460-103
11-digit product format
844600103
Labeler code
84460
Product ID
84460-103_2dd5226c-e7e1-cca0-e063-6394a90a32a5
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate 10%
Dosage form
PATCH
Route
TOPICAL
Labeler
Florrax Pharmaceutical Corp.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
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
2dd5226c-e7e0-cca0-e063-6394a90a32a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84460-103-01Methyl Salicylate2 in 1 BOXPATCH21
84460-103-01Methyl Salicylate5 in 1 POUCHPATCH51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84460-103-01EA - Each84460-10311186450-2d00-453f-9bd4-222ae6c6fb7912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84460-103METHYL SALICYLATE (METHYL SALICYLATE 10%) PATCH [FLORRAX PHARMACEUTICAL CORP.]1Current NDC, 2 package rows20250221_2dd5226c-e7e0-cca0-e063-6394a90a32a5.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 SALICYLATE 10%Florrax Pharmaceutical Corp.2dd5226c-e7e0-cca0-e063-6394a90a32a52025-02-10WarningsExact identifier
ndc (product): 84460-103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053397methyl salicylate 10 % Medicated PatchPSN2dd5226c-e7e0-cca0-e063-6394a90a32a51
1053397methyl salicylate 0.1 MG/MG Medicated PatchSCD2dd5226c-e7e0-cca0-e063-6394a90a32a51
1053397methyl salicylate 10 % Medicated PatchSY2dd5226c-e7e0-cca0-e063-6394a90a32a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84460-103-01844600103012 POUCH in 1 BOX (84460-103-01) / 5 PATCH in 1 POUCH / 100 g in 1 PATCH2 pouch2025-02-10NoNoCurrent