FDA.reportPublic FDA data

Eclipse Topical Analgesic

Product NDC
54723-669
11-digit product format
547230669
Labeler code
54723
Product ID
54723-669_a3801b6f-fc54-4ad9-88c0-2dc968ab75cb
Type
HUMAN OTC DRUG
Nonproprietary name
Tetracaine HCL
Dosage form
CREAM
Route
TOPICAL
Labeler
Sambria Pharmaceuticals, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
TETRACAINE HYDROCHLORIDE
Active strength
20 mg/1000mg
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
54723-669-032021-07-23C16284748780-1c7ccaba7-2118-fd44-e053-dadaa90aa01bEclipse LL Topical Analgesic
54723-669-052021-07-23C16284748780-1c7ccaba7-24cc-fd44-e053-dadaa90aa01bEclipse LL Topical Analgesic
54723-669-092021-07-23C16284748780-1c7ccaba7-12cf-fd44-e053-dadaa90aa01bEclipse LL Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-669-05Eclipse Topical AnalgesicLL5 mg in 1 PACKETCREAM53
54723-669-03Eclipse Topical AnalgesicLL3000 mg in 1 PACKETCREAM30002
54723-669-09Eclipse Topical AnalgesicLL1500 mg in 1 PACKETCREAM15002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-669ECLIPSE TOPICAL ANALGESIC LL (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20191227_bb67a8d2-8799-4672-ac4a-a9124f1f543f.zip
54723-669ECLIPSE TOPICAL ANALGESIC LL (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20191227_6e0e3594-0c69-495e-9972-13af2773c88d.zip
54723-669ECLIPSE TOPICAL ANALGESIC LL (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20191227_be19e1aa-0dae-4534-8cff-2af13347e963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543158tetracaine HCl 2 % Topical CreamPSNbb67a8d2-8799-4672-ac4a-a9124f1f543f3
1543158tetracaine hydrochloride 20 MG/ML Topical CreamSCDbb67a8d2-8799-4672-ac4a-a9124f1f543f3
1543158tetracaine HCl 2 % Topical CreamSYbb67a8d2-8799-4672-ac4a-a9124f1f543f3
1543158tetracaine HCl 2 % Topical CreamPSN6e0e3594-0c69-495e-9972-13af2773c88d2
1543158tetracaine HCl 2 % Topical CreamPSNbe19e1aa-0dae-4534-8cff-2af13347e9632
1543158tetracaine hydrochloride 20 MG/ML Topical CreamSCD6e0e3594-0c69-495e-9972-13af2773c88d2
1543158tetracaine hydrochloride 20 MG/ML Topical CreamSCDbe19e1aa-0dae-4534-8cff-2af13347e9632
1543158tetracaine HCl 2 % Topical CreamSY6e0e3594-0c69-495e-9972-13af2773c88d2
1543158tetracaine HCl 2 % Topical CreamSYbe19e1aa-0dae-4534-8cff-2af13347e9632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54723-669-03547230669033000 mg in 1 PACKET (54723-669-03) 3000 mg2016-02-010000-00-00NoNoCurrent
54723-669-05547230669055 mg in 1 PACKET (54723-669-05) 5 mg2017-05-010000-00-00NoNoCurrent
54723-669-09547230669091500 mg in 1 PACKET (54723-669-09) 1500 mg2016-02-010000-00-00NoNoCurrent