Salicate

Product NDC
59088-214
Requested package NDC
59088-214-03
11-digit product format
590880214
Labeler code
59088
Product ID
59088-214_fd699cfb-8ca0-ebb8-e053-6394a90ace4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Salicylic Acid 10%
Dosage form
GEL
Route
TOPICAL
Labeler
PureTek Coproration
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-13
Substance
SALICYLIC ACID
Active strength
10 mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Salicate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd699cfb-8c9f-ebb8-e053-6394a90ace4aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-214-03Salicate30 mL in 1 BOTTLE, DROPPERGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-214SALICATE (SALICYLIC ACID 10%) GEL [PURETEK COPRORATION]1Current NDC, 1 package rows20231014_fd699cfb-8c9f-ebb8-e053-6394a90ace4a.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
SalicateSALICYLIC ACID 10%PureTek Coprorationfd699cfb-8c9f-ebb8-e053-6394a90ace4a2023-10-13Warnings, Adverse reactionsExact identifier
ndc (package): 59088-214-03
ndc (product): 59088-214
ndc11 (package): 59088021403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-214-035908802140330 mL in 1 BOTTLE, DROPPER (59088-214-03) 30 ml2023-10-13NoNoCurrent