FDA.reportPublic FDA data

phenylephrine hydrochloride

Product NDC
50730-4812
11-digit product format
507304812
Labeler code
50730
Product ID
50730-4812_1065863d-fc11-4ca8-86f2-76ba8eba05c5
Type
HUMAN OTC DRUG
Nonproprietary name
phenylephrine hydrochloride
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
H and P Industries, Inc. dba Triad Group
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-03-01
Marketing end
0000-00-00
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL
Active strength
2077 mg/1; mg/1; 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
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
50730-4812-02019-10-21C16284748780-1956f9ecf-ca08-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50730-4812-0phenylephrine hydrochloride12 in 1 BOXSUPPOSITORY121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cocoa butterACTIVE INGREDIENT512OYT1CRRPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
shark liver oilACTIVE INGREDIENT4B24275HEUPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
cocoa butterACTIVE MOIETY512OYT1CRRPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
phenylephrineACTIVE MOIETY1WS297W6MVPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
shark liver oilACTIVE MOIETY4B24275HEUPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJPHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50730-4812PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1Legacy NDC, 1 package rows20091209_054fc819-6fbb-483e-89fb-71b58d094c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259093cocoa butter 85.5 % / phenylephrine HCl 0.25 % / shark liver oil 3 % Rectal SuppositoryPSN054fc819-6fbb-483e-89fb-71b58d094c9b1
259093cocoa butter 0.855 MG/MG / phenylephrine 0.0025 MG/MG / shark liver oil 0.03 MG/MG Rectal SuppositorySCD054fc819-6fbb-483e-89fb-71b58d094c9b1
259093cocoa butter 85.5 % / phenylephrine 0.25 % / shark liver oil preparation 3 % Rectal SuppositorySY054fc819-6fbb-483e-89fb-71b58d094c9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50730-4812-05073048120012 in 1 BOXHistorical