FDA.reportPublic FDA data

Methyl Salicylate 25% Cream

Product NDC
80425-0544
11-digit product format
804250544
Labeler code
80425
Product ID
80425-0544_3bdd3021-d16d-12ea-e063-6394a90ab1e0
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
CREAM
Route
CUTANEOUS
Labeler
Advanced Rx of Tennessee, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-08
Substance
METHYL SALICYLATE
Active strength
250 mg/g
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 25% Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE250 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLAV5U5022Y
Rxcui238542

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
80425-0544-1Methyl Salicylate 25% Cream120 g in 1 TUBECREAM1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0544-1GM - Gram80425-0544a501e4a7-b11a-4bea-8338-523a961cfc7f12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238542methyl salicylate 25 % Topical CreamPSN3bdd3015-349a-0fac-e063-6394a90afe411
238542methyl salicylate 250 MG/ML Topical CreamSCD3bdd3015-349a-0fac-e063-6394a90afe411
238542methyl salicylate 25 % Topical CreamSY3bdd3015-349a-0fac-e063-6394a90afe411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0544-180425054401120 g in 1 TUBE (80425-0544-1) 120 g2025-08-08NoNoHistorical