FDA.reportPublic FDA data

SALYCIM

Product NDC
59088-227
Requested package NDC
59088-227-05
11-digit product format
590880227
Labeler code
59088
Product ID
59088-227_17d2437e-8a89-f4b7-e063-6294a90aaebd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
PURETEK CORPORATION
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-06
Substance
SALICYLIC ACID
Active strength
60 mg/g
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
SALYCIM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID60 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477031Internal RxNorm lookup
2671250Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc745524-9b5a-e6d9-e053-6394a90ae7baAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-227-05SALYCIM57 g in 1 JARCREAM572

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-227-05GM - Gram59088-2270887fe98-a11e-445d-b930-ee880c083c4212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-227SALYCIM (SALICYLIC ACID) CREAM [PURETEK CORPORATION]2Current NDC, 1 package rows20240508_fc745524-9b5a-e6d9-e053-6394a90ae7ba.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
SALYCIMSALICYLIC ACIDPURETEK CORPORATIONfc745524-9b5a-e6d9-e053-6394a90ae7ba2024-05-06Warnings, Adverse reactionsExact identifier
ndc (package): 59088-227-05
ndc (product): 59088-227
ndc11 (package): 59088022705

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477031salicylic acid 6 % Topical CreamPSNfc745524-9b5a-e6d9-e053-6394a90ae7ba2
2671250Salycim 6 % Topical CreamPSNfc745524-9b5a-e6d9-e053-6394a90ae7ba2
2671250salicylic acid 60 MG/ML Topical Cream [Salycim]SBDfc745524-9b5a-e6d9-e053-6394a90ae7ba2
477031salicylic acid 60 MG/ML Topical CreamSCDfc745524-9b5a-e6d9-e053-6394a90ae7ba2
477031salicylic acid 6 % Topical CreamSYfc745524-9b5a-e6d9-e053-6394a90ae7ba2
2671250Salycim 60 MG/ML Topical CreamSYfc745524-9b5a-e6d9-e053-6394a90ae7ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-227-055908802270557 g in 1 JAR (59088-227-05) 57 g2023-12-06NoNoCurrent