FDA.reportPublic FDA data

NDC 68016-321-12 - Premier Value Hemorrhoidal

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68016-321
Requested NDC
68016-321-12
Package NDCs from labels
68016-321-12, 68016-321-13
Manufacturer
Chain Drug Consortium | Unipack, Inc.
Effective date
2015-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Premier Value Hemorrhoidal - Chain Drug Consortium | Unipack, Inc.Chain Drug Consortium | Unipack, Inc.2015-03-25HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-321-132020-01-31C16284748780-19d75b9d0-b2f6-f424-e053-dadaa90a57ce8638a48e-9f90-4cab-abc1-5407afe498df

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-321-12Premier Value Hemorrhoidal12 g in 1 BLISTER PACKSUPPOSITORY121
68016-321-13Premier Value Hemorrhoidal2 in 1 CARTONSUPPOSITORY21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-321PREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1Legacy NDC, 2 package rows20150326_8638a48e-9f90-4cab-abc1-5407afe498df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-321-12EA - Each68016-3211a6ae44e-c6c1-42f0-89f2-30174dbf5f6712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRPREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRPREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TPREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREMIER VALUE HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 52 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB9cbb3ab1-5f32-421e-9f28-d99be9447e9f2024-10-21WarningsExact identifier
unii: 04JA59TNSJ
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb791902-e2c3-5662-e053-2995a90a37fd2024-10-21WarningsExact identifier
unii: 04JA59TNSJ
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBc3849b66-697f-4f6e-93ab-76de031b3c702024-10-21WarningsExact identifier
unii: 04JA59TNSJ
DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB774e8bee-1ab5-4587-82e4-31da8ec835442024-10-21WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba8ade-3441-f243-e053-2995a90a12302024-10-21WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba22ac-c38d-a42e-e053-2995a90a69002024-10-21WarningsExact identifier
unii: 04JA59TNSJ
Tukol Honey Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAdae33df8-2294-4242-a25b-2d89d1f63b232024-10-18WarningsExact identifier
unii: 04JA59TNSJ
sinus pressure and pain peACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa7931e4c-8a5e-66e2-e053-2995a90af2a42024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense570ea130-6a99-446e-9f97-14fc958090062024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa14999e3-a9d9-0a1f-e053-2995a90af7b32024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa793000b-3ef9-5662-e053-2a95a90ad0da2024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3396a27-8643-71fa-e053-2a95a90a713d2024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3397f69-3267-ca0b-e053-2995a90a7db52024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense747512a2-3b6d-496b-ab80-8190603141632024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN9daf7f40-d9c5-4367-be41-894208358fc12024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen608e6808-29e4-40bc-8496-24c092681a1b2024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen665db127-ee04-46c4-bff0-e0fe9950c3e22024-10-18WarningsExact identifier
unii: 04JA59TNSJ
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen604d7e53-4bfd-4cdd-aed2-b304ae82ce442024-10-18WarningsExact identifier
unii: 04JA59TNSJ
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLMeijer Distribution Inc1431397e-3515-4794-a494-70667948e14c2024-10-18WarningsExact identifier
rxcui: 1438497
unii: 512OYT1CRR
unii: 04JA59TNSJ
signature care hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSafewayafcf68cf-f187-44d3-ad91-b1e79b182bc62024-10-17WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.