FDA.reportPublic FDA data

CALCIPOTRIENE 0.005% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:42

Label at a glance#

ProductCALCIPOTRIENE 0.005% / NIACINAMIDE 4%
Active ingredientNIACINAMIDE, CALCIPOTRIENE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

qdqd

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

ss

Active, inactive

COMPONENTS

sdsd

NDC 72934- 2033-2 CALCIPOTRIENE 0.005% / NIACINAMIDE 4%. Cream 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cc

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIPOTRIENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2033-22021-01-29C16284748780-1ba0f9c33-1c4f-a910-e053-dadaa90a0b85CALCIPOTRIENE 0.005% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2033-2CALCIPOTRIENE 0.005% / NIACINAMIDE 4%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2033CALCIPOTRIENE 0.005% / NIACINAMIDE 4% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190514_88c5f47f-1fb4-7b0a-e053-2a95a90a5171.zip

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
72934-203372934-2033-2

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
NIACINAMIDE25X51I8RD4ACTIB
CALCIPOTRIENE143NQ3779BACTIB

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
88c5f47f-1fb5-7b0a-e053-2a95a90a517188c5f47f-1fb4-7b0a-e053-2a95a90a51712019-05-13Adverse reactionsExact identifier
spl id: 88c5f47f-1fb5-7b0a-e053-2a95a90a5171
spl set id: 88c5f47f-1fb4-7b0a-e053-2a95a90a5171

Reported adverse events (FAERS/openFDA)#

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