FDA.reportPublic FDA data

TACROLIMUS 0.1% IN PSEUDOCATALASE

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#

ProductTACROLIMUS 0.1% IN PSEUDOCATALASE
Active ingredientTACROLIMUS
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

dd

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

nn

Active, inactive

COMPONENTS

dd

NDC 72934-2174-2 / TACROLIMUS USP 0.1%. Cream 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ss

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
72934-2174-22021-01-29C16284748780-1ba0f9c33-44af-a910-e053-dadaa90a0b85TACROLIMUS 0.1% IN PSEUDOCATALASE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2174-2TACROLIMUS 0.1% IN PSEUDOCATALASE30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2174TACROLIMUS 0.1% IN PSEUDOCATALASE CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190502_874b82c6-ef05-8ce2-e053-2a95a90a5695.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-2174-2GM - Gram72934-217494304960-da82-45b2-b568-eac50e3cbd9712020-03-10

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-217472934-2174-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TACROLIMUSWM0HAQ4WNMACTIM

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
874b82c6-ef06-8ce2-e053-2a95a90a5695874b82c6-ef05-8ce2-e053-2a95a90a56952019-04-24Adverse reactionsExact identifier
spl id: 874b82c6-ef06-8ce2-e053-2a95a90a5695
spl set id: 874b82c6-ef05-8ce2-e053-2a95a90a5695

Reported adverse events (FAERS/openFDA)#

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