FDA.reportPublic FDA data

Methyl Salicylate 25%

Product NDC
82944-105
11-digit product format
829440105
Labeler code
82944
Product ID
82944-105_508846d6-1437-c437-e063-6294a90a07d6
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate 25%
Dosage form
PATCH
Route
TOPICAL
Labeler
iON Pharma, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
Substance
METHYL SALICYLATE
Active strength
25 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methyl Salicylate 25%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE25 g/1

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
2704558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a3fc367-ed4d-ce94-e063-6294a90aaf7cAvailable 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
82944-105-30Methyl Salicylate 25%1 in 1 BOXPATCH13
82944-105-30Methyl Salicylate 25%30 in 1 POUCHPATCH303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82944-105-30EA - Each82944-105f5b5ffbe-9311-4b32-91f2-77d0cfb8d64f12025-08-11

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 Salicylate 25%METHYL SALICYLATE 25%iON Pharma, LLC3a3fc367-ed4d-ce94-e063-6294a90aaf7c2026-04-28WarningsExact identifier
ndc (product): 82944-105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2704558methyl salicylate 25 % Medicated PatchPSN3a3fc367-ed4d-ce94-e063-6294a90aaf7c3
2704558methyl salicylate 0.25 MG/MG Medicated PatchSCD3a3fc367-ed4d-ce94-e063-6294a90aaf7c3
2704558methyl salicylate 25 % Medicated PatchSY3a3fc367-ed4d-ce94-e063-6294a90aaf7c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82944-105-30829440105301 POUCH in 1 BOX (82944-105-30) / 30 PATCH in 1 POUCH / 1 PATCH in 1 PATCH1 pouch2025-04-01NoNoCurrent