FDA.reportPublic FDA data

Salicylic Acid 6% Gel

Product NDC
59088-261
11-digit product format
590880261
Labeler code
59088
Product ID
59088-261_4dcb122e-f62b-eb0a-e063-6294a90a579a
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
6 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 ACID6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312893Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41eaa88c-a980-ea4f-e063-6294a90a411aAvailable 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
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

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
Salicylic Acid 6% GelSALICYLIC ACIDPureTek Corporation41eaa88c-a980-ea4f-e063-6294a90a411a2026-03-24Warnings, Adverse reactionsExact identifier
ndc (product): 59088-261

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
59088-261-035908802610329.57 mL in 1 TUBE (59088-261-03) 29.57 ml2026-02-19NoNoCurrent