FDA.reportPublic FDA data

COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE

Product NDC
59779-401
11-digit product format
597790401
Labeler code
59779
Product ID
59779-401_01e14dd4-f3d2-4aee-89d5-c1df553f1ffd
Type
HUMAN OTC DRUG
Nonproprietary name
COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
CVS
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
1 g/g; g/g
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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-401-442019-10-29C16284748780-1960f7f55-c1fa-8e05-e053-dbdaa90a074adrug facts
59779-401-452019-10-29C16284748780-1960f7f55-c1fa-8e05-e053-dbdaa90a074adrug facts
59779-401-462019-10-29C16284748780-1960f7f55-c1fa-8e05-e053-dbdaa90a074adrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-401-44COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE30 g in 1 BOXSUPPOSITORY302
59779-401-45COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE60 g in 1 BOXSUPPOSITORY602
59779-401-46COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE120 g in 1 BOXSUPPOSITORY1202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2
COCOA BUTTERACTIVE MOIETY512OYT1CRRCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-401COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]2Legacy NDC, 3 package rows20110721_79aba427-9500-4689-a2a3-c8128eb08398.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114865cocoa butter 85.5 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN79aba427-9500-4689-a2a3-c8128eb083982
1114865cocoa butter 0.855 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD79aba427-9500-4689-a2a3-c8128eb083982
1114865cocoa butter 85.5 % / phenylephrine HCl 0.25 % Rectal SuppositorySY79aba427-9500-4689-a2a3-c8128eb083982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59779-401-445977904014430 g in 1 BOX30 gHistorical
59779-401-455977904014560 g in 1 BOX60 gHistorical
59779-401-4659779040146120 g in 1 BOX120 gHistorical