FDA.reportPublic FDA data

Methyl Salicylate 10%

Product NDC
85231-101
11-digit product format
852310101
Labeler code
85231
Product ID
85231-101_36f75a71-4cab-413e-e063-6394a90a8f55
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
ViolaCare, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
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 10%
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
af2bbcb8-c04c-4f55-84be-2519642f9260Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85231-101-15Methyl Salicylate 10%1 in 1 POUCHPATCH12
85231-101-15Methyl Salicylate 10%15 in 1 BOXPATCH152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85231-101-15EA - Each85231-1016700f871-43c2-479c-8a2a-7e6941c27cfe12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85231-101METHYL SALICYLATE 10% (METHYL SALICYLATE) PATCH [VIOLACARE, INC.]1Current NDC, 2 package rows20250515_af2bbcb8-c04c-4f55-84be-2519642f9260.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 SALICYLATEViolaCare, Inc.af2bbcb8-c04c-4f55-84be-2519642f92602025-06-07WarningsExact identifier
ndc (product): 85231-101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053397methyl salicylate 10 % Medicated PatchPSNaf2bbcb8-c04c-4f55-84be-2519642f92602
1053397methyl salicylate 0.1 MG/MG Medicated PatchSCDaf2bbcb8-c04c-4f55-84be-2519642f92602
1053397methyl salicylate 10 % Medicated PatchSYaf2bbcb8-c04c-4f55-84be-2519642f92602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85231-101-158523101011515 POUCH in 1 BOX (85231-101-15) / 1 PATCH in 1 POUCH / 10 g in 1 PATCH15 pouch2025-05-01NoNoCurrent