FDA.reportPublic FDA data

CALCIPOTRIENE

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:37

Label at a glance#

ProductCALCIPOTRIENE 0.005% / DICLOFENAC SODIUM 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE 2%
Active ingredientCALCIPOTRIENE, DICLOFENAC SODIUM, HYALURONATE SODIUM, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

cc

ADVERSE REACTIONS SECTION

zczc

Active, inactive

COMPONENTS

axsaxs

NDC 72934-2030-2 CALCIPOTRIENE USP 0.005% / DICLOFENAC SODIUM USP 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE USP 2%. Cream 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dsds

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIPOTRIENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DICLOFENAC Pharmacologic Class Indexing2Indexing - Pharmacologic Class20190118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2030-22021-01-29C16284748780-1ba0f9c33-26da-a910-e053-dadaa90a0b85CALCIPOTRIENE 0.005% / DICLOFENAC SODIUM 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2030-2CALCIPOTRIENE 0.005% / DICLOFENAC SODIUM 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE 2%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2030CALCIPOTRIENE 0.005% / DICLOFENAC SODIUM 3% / HYALURONIC ACID SODIUM SALT 2% / NIACINAMIDE 2% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190507_883e1f59-2a7a-1ccd-e053-2995a90a1ef0.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-203072934-2030-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIPOTRIENE143NQ3779BACTIB
DICLOFENAC SODIUMQTG126297QACTIB
HYALURONATE SODIUMYSE9PPT4THACTIB
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
883e1f59-2a7b-1ccd-e053-2995a90a1ef0883e1f59-2a7a-1ccd-e053-2995a90a1ef02019-05-06Adverse reactionsExact identifier
spl id: 883e1f59-2a7b-1ccd-e053-2995a90a1ef0
spl set id: 883e1f59-2a7a-1ccd-e053-2995a90a1ef0

Reported adverse events (FAERS/openFDA)#

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