FDA.reportPublic FDA data

Salicylic Acid 6% Gel

Product NDC
59088-261
11-digit product format
590880261
Labeler code
59088
Product ID
59088-261_5c3e95db-a313-9f72-e063-6394a90a02f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-02-19
Substance
SALICYLIC ACID
Active strength
60 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Salicylic Acid 6% Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID60 mg/g

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
59088-261-03Salicylic Acid 6% Gel29.57 mL in 1 TUBEGEL29.573

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-261-03GM - Gram59088-26190058f7a-95fb-4038-861b-b83cd4eb937712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312893salicylic acid 6 % Topical GelPSN41eaa88c-a980-ea4f-e063-6294a90a411a3
312893salicylic acid 0.06 MG/MG Topical GelSCD41eaa88c-a980-ea4f-e063-6294a90a411a3
312893salicylic acid 6 % Topical GelSY41eaa88c-a980-ea4f-e063-6294a90a411a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-261-035908802610328.35 g in 1 TUBE (59088-261-03) 28.35 g2026-02-19NoNoCurrent