FDA.reportPublic FDA data

COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE

Product NDC
11673-395
11-digit product format
116730395
Labeler code
11673
Product ID
11673-395_95b7740d-99bb-4dda-910a-0a1e95d62e17
Type
HUMAN OTC DRUG
Nonproprietary name
COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Target Corporation
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
850 mg/g; mg/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
11673-395-602019-10-29C16284748780-1960f7f55-d472-8e05-e053-dbdaa90a074adrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-395-60COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE12 in 1 CARTONSUPPOSITORY121
11673-395-60COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE2.5 g in 1 PACKETSUPPOSITORY2.51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-395COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [TARGET CORPORATION]1Legacy NDC, 2 package rows20110726_21744505-0fbc-4e74-bd8f-e1ae5e322f9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114865cocoa butter 85.5 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN21744505-0fbc-4e74-bd8f-e1ae5e322f9f1
1114865cocoa butter 0.855 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD21744505-0fbc-4e74-bd8f-e1ae5e322f9f1
1114865cocoa butter 85.5 % / phenylephrine HCl 0.25 % Rectal SuppositorySY21744505-0fbc-4e74-bd8f-e1ae5e322f9f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11673-395-601167303956012 in 1 CARTONHistorical