FDA.reportPublic FDA data

Methyl Salicylate 10%

Product NDC
82944-101
11-digit product format
829440101
Labeler code
82944
Product ID
82944-101_21c537e5-7b9a-dd80-e063-6394a90a4ceb
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
ION PHARMA, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
METHYL SALICYLATE
Active strength
10 g/1
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 10%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 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
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
11a6d22a-1a7a-4c76-b873-fffd00ac4b54Available 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
82944-101-10Methyl Salicylate 10%5 in 1 POUCHPATCH52
82944-101-10Methyl Salicylate 10%10 in 1 BOXPATCH102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82944-101-10EA - Each82944-1015ee3abf7-dbb8-4034-9642-b5509129086d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82944-101METHYL SALICYLATE 10% (METHYL SALICYLATE) PATCH [ION PHARMA, LLC]2Current NDC, 2 package rows20241020_11a6d22a-1a7a-4c76-b873-fffd00ac4b54.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 Salicylate 10%METHYL SALICYLATEION PHARMA, LLC11a6d22a-1a7a-4c76-b873-fffd00ac4b542026-04-28WarningsExact identifier
ndc (product): 82944-101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053397methyl salicylate 10 % Medicated PatchPSN11a6d22a-1a7a-4c76-b873-fffd00ac4b542
1053397methyl salicylate 0.1 MG/MG Medicated PatchSCD11a6d22a-1a7a-4c76-b873-fffd00ac4b542
1053397methyl salicylate 10 % Medicated PatchSY11a6d22a-1a7a-4c76-b873-fffd00ac4b542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82944-101-108294401011010 POUCH in 1 BOX (82944-101-10) / 5 PATCH in 1 POUCH10 pouch2023-06-01NoNoCurrent