FranklyNumb 3

Product NDC
54723-004
11-digit product format
547230004
Labeler code
54723
Product ID
54723-004_d2a9bc7e-5b51-dfbd-e053-2995a90a4e29
Type
HUMAN OTC DRUG
Nonproprietary name
Tetracaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Sambria Pharmaceuticals, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-12-08
Marketing end
0000-00-00
Substance
TETRACAINE
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54723-004-012023-01-30C16284748780-1f386c649-b56e-0266-e053-dadaa90a7c1a5b56e35b-8a46-4b95-8e7a-4237710efd85

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-004-01FranklyNumb 34 mL in 1 POUCHCREAM42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-004FRANKLYNUMB 3 (TETRACAINE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]2Legacy NDC, 1 package rows20211209_5b56e35b-8a46-4b95-8e7a-4237710efd85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1733865tetracaine 2 % Topical CreamPSN5b56e35b-8a46-4b95-8e7a-4237710efd852
1733865tetracaine 20 MG/ML Topical CreamSCD5b56e35b-8a46-4b95-8e7a-4237710efd852
1733865tetracaine 2 % Topical CreamSY5b56e35b-8a46-4b95-8e7a-4237710efd852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54723-004-01547230004014 mL in 1 POUCH (54723-004-01) 4 ml2021-12-080000-00-00NoNoCurrent