Burn Cream

Product NDC
37945-212
11-digit product format
379450212
Labeler code
37945
Product ID
37945-212_9a00dfce-2ac0-1632-e053-2995a90a3f4a
Type
HUMAN OTC DRUG
Nonproprietary name
tetracaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bio-Medical & Pharmaceutical Manufacturing Corporation
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-08-19
Marketing end
0000-00-00
Substance
TETRACAINE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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
37945-212-352024-01-30C16284748780-11030e365-19ac-111a-e063-dadaa90a10e23a477714-6ff3-62aa-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37945-212-34Burn Cream10 mL in 1 TUBECREAM102
37945-212-35Burn Cream12 in 1 BOXCREAM122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37945-212BURN CREAM (TETRACAINE) CREAM [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]2Legacy NDC, 2 package rows20191219_3a477714-6ff3-62aa-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313246tetracaine HCl 1 % Topical CreamPSN3a477714-6ff3-62aa-e054-00144ff8d46c2
313246tetracaine 10 MG/ML Topical CreamSCD3a477714-6ff3-62aa-e054-00144ff8d46c2
313246tetracaine 1 % Topical CreamSY3a477714-6ff3-62aa-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37945-212-343794502123410 mL in 1 TUBE10 mlHistorical
37945-212-353794502123512 TUBE in 1 BOX (37945-212-35) > 10 mL in 1 TUBE (37945-212-34) 12 tube2016-08-190000-00-00NoNoCurrent