FDA.reportPublic FDA data

cocoa butter, phenylephrine hydrochloride, shark liver oil

Product NDC
50730-1481
11-digit product format
507301481
Labeler code
50730
Product ID
50730-1481_ec714dbf-89f7-476e-bad9-a8ef85aa6837
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine hydrochloride, shark liver oil
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
H and P Industries, Inc. dba Triad Group
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-03-06
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50730-1481-12019-10-21C16284748780-1956f9ecf-c075-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50730-1481-1cocoa butter, phenylephrine hydrochloride, shark liver oil12 in 1 BOXSUPPOSITORY121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cocoa butterACTIVE INGREDIENT512OYT1CRRCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
shark liver oilACTIVE INGREDIENT4B24275HEUCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
cocoa butterACTIVE MOIETY512OYT1CRRCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
phenylephrineACTIVE MOIETY1WS297W6MVCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
shark liver oilACTIVE MOIETY4B24275HEUCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50730-1481COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1Legacy NDC, 1 package rows20091120_e56eb547-9a1f-4f37-a0f6-95b3c1f27e65.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 SuppositoryPSNe56eb547-9a1f-4f37-a0f6-95b3c1f27e651
259093cocoa butter 0.855 MG/MG / phenylephrine 0.0025 MG/MG / shark liver oil 0.03 MG/MG Rectal SuppositorySCDe56eb547-9a1f-4f37-a0f6-95b3c1f27e651
259093cocoa butter 85.5 % / phenylephrine 0.25 % / shark liver oil preparation 3 % Rectal SuppositorySYe56eb547-9a1f-4f37-a0f6-95b3c1f27e651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50730-1481-15073014810112 in 1 BOXHistorical