FDA.reportPublic FDA data

Cepastat

Product NDC
63736-219
11-digit product format
637360219
Labeler code
63736
Product ID
63736-219_a33617f8-fc6a-4c06-8f96-fed5b5d6d570
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
LOZENGE
Route
ORAL
Labeler
Insight Pharmaceuticals
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-07-07
Marketing end
0000-00-00
Substance
PHENOL
Active strength
29 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-219-182019-10-21C16284748780-1956f9ecf-c5a9-621f-e053-dbdaa90a74adCĒPASTAT ® ORAL ANESTHETIC WITH PHENOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-219-18CepastatExtra Strength18 in 1 BOXLOZENGE181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63736-219-18EA - Each63736-2195124ec95-f64c-4d13-addf-c685b984e70612018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenolACTIVE INGREDIENT339NCG44TVCEPASTAT EXTRA STRENGTH (PHENOL) LOZENGE [INSIGHT PHARMACEUTICALS]1
PhenolACTIVE MOIETY339NCG44TVCEPASTAT EXTRA STRENGTH (PHENOL) LOZENGE [INSIGHT PHARMACEUTICALS]1
CaramelINACTIVE INGREDIENTT9D99G2B1RCEPASTAT EXTRA STRENGTH (PHENOL) LOZENGE [INSIGHT PHARMACEUTICALS]1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662CEPASTAT EXTRA STRENGTH (PHENOL) LOZENGE [INSIGHT PHARMACEUTICALS]1
MentholINACTIVE INGREDIENTL7T10EIP3ACEPASTAT EXTRA STRENGTH (PHENOL) LOZENGE [INSIGHT PHARMACEUTICALS]1
SorbitolINACTIVE INGREDIENT506T60A25RCEPASTAT EXTRA STRENGTH (PHENOL) LOZENGE [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-219CEPASTAT EXTRA STRENGTH (PHENOL) LOZENGE [INSIGHT PHARMACEUTICALS]1Legacy NDC, 1 package rows20090715_1613c687-411e-487d-b672-a3d849d53e5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242123CEPASTAT 29 MG Oral LozengePSN1613c687-411e-487d-b672-a3d849d53e5f1
485291phenol 29 MG Oral LozengePSN1613c687-411e-487d-b672-a3d849d53e5f1
1242123phenol 29 MG Oral Lozenge [Cepastat]SBD1613c687-411e-487d-b672-a3d849d53e5f1
485291phenol 29 MG Oral LozengeSCD1613c687-411e-487d-b672-a3d849d53e5f1
1242123Cepastat 29 MG Oral LozengeSY1613c687-411e-487d-b672-a3d849d53e5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63736-219-186373602191818 in 1 BOXHistorical