FDA.reportPublic FDA data

NIACINAMIDE 4% / TACROLIMUS 0.1%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:31

Label at a glance#

ProductNIACINAMIDE 4% / TACROLIMUS 0.1%
Active ingredientTACROLIMUS, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

cc

ADVERSE REACTIONS SECTION

ww

Active, inactive

COMPONENTS

ss

NDC 72934-5159-2 NIACINAMIDE USP 4% / TACROLIMUS USP 0.1%. Ointment 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dd

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TACROLIMUS ANHYDROUS Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
df369ad4-19d8-393a-de46-8c6255b8b360Product name820251120
d2a74186-7b26-dbcc-9435-50b3d0be14abProduct name220250114
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-5159-22021-01-29C16284748780-1ba0f9c33-4f31-a910-e053-dadaa90a0b85NIACINAMIDE 4% / TACROLIMUS 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-5159-2NIACINAMIDE 4% / TACROLIMUS 0.1%30 g in 1 BOTTLE, PUMPOINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-5159NIACINAMIDE 4% / TACROLIMUS 0.1% OINTMENT [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190502_874bbbd4-1253-2867-e053-2995a90a8593.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-5159-2GM - Gram72934-515942b693cd-d422-4bc4-8928-0bd383c7e7cb12020-03-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-515972934-5159-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TACROLIMUSWM0HAQ4WNMACTIM
NIACINAMIDE25X51I8RD4ACTIB

Source Document#

Source XML

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
874bbbd4-1254-2867-e053-2995a90a8593874bbbd4-1253-2867-e053-2995a90a85932019-04-24Adverse reactionsExact identifier
spl id: 874bbbd4-1254-2867-e053-2995a90a8593
spl set id: 874bbbd4-1253-2867-e053-2995a90a8593

Reported adverse events (FAERS/openFDA)#

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