FDA.reportPublic FDA data

Fluocinol Pak

Product NDC
59088-755
11-digit product format
590880755
Labeler code
59088
Product ID
59088-755_f2051c68-cdea-58b2-e053-2995a90a6b48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOCINONIDE
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-07-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinol Pak
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485647Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9c88a41-3ff8-78f7-e053-2995a90adb8fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-151-94Fluocinol Pak1 in 1 CARTONCREAM1 mg in 1g4
45802-151-94Fluocinol Pak30 g in 1 TUBECREAM30 g1 mg in 1g4
59088-755-00Fluocinol Pak1 in 1 KITKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-755FLUOCINOL PAK (FLUOCINONIDE) KIT [PURETEK CORPORATION]4Current NDC, Legacy NDC, 3 package rows20230112_a9c88a41-3ff8-78f7-e053-2995a90adb8f.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
Fluocinol PakFLUOCINONIDEPureTek Corporationa9c88a41-3ff8-78f7-e053-2995a90adb8f2023-01-11Warnings, Adverse reactionsExact identifier
ndc (product): 59088-755

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSNa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 1 MG/ML Topical CreamSCDa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 0.1 % Topical CreamSYa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 1 MG per 1 GM Topical CreamSYa9c88a41-3ff8-78f7-e053-2995a90adb8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-151-94458020151941 in 1 CARTONHistorical
59088-755-00590880755001 KIT in 1 KIT (59088-755-00) * 1 TUBE in 1 CARTON (45802-151-94) / 30 g in 1 TUBE1 kit2020-07-020000-00-00NoNoCurrent