FDA.reportPublic FDA data

Calyxra

Product NDC
84460-803
11-digit product format
844600803
Labeler code
84460
Product ID
84460-803_06be3d58-249c-49e1-9756-d19880bd606c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene Cream, 0.005%
Dosage form
KIT
Labeler
Florrax Pharmaceutical
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-01-13
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calyxra
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313921Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b18f6071-7be6-4ae0-b4a0-22353fc4263eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-501-65Calyxra1 in 1 CARTONCREAM50 ug in 1g2
68462-501-65Calyxra60 g in 1 TUBECREAM60 g50 ug in 1g2
84460-803-01Calyxra1 in 1 KITKIT12

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
CalyxraCALCIPOTRIENE CREAM, 0.005%Florrax Pharmaceuticalb18f6071-7be6-4ae0-b4a0-22353fc4263e2026-03-24Warnings, Adverse reactionsExact identifier
ndc (product): 84460-803

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSNb18f6071-7be6-4ae0-b4a0-22353fc4263e2
313921calcipotriene 0.05 MG/ML Topical CreamSCDb18f6071-7be6-4ae0-b4a0-22353fc4263e2
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYb18f6071-7be6-4ae0-b4a0-22353fc4263e2
313921calcipotriene 0.005 % Topical CreamSYb18f6071-7be6-4ae0-b4a0-22353fc4263e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-501-65684620501651 in 1 CARTONHistorical
84460-803-01844600803011 KIT in 1 KIT (84460-803-01) * 1 TUBE in 1 CARTON (68462-501-65) / 60 g in 1 TUBE * 10 in 1 BOX1 kit2026-03-24NoNoCurrent