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 53 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART62c35320-87b5-46e2-9f6f-cb0882bdb52e2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dcf6cf-373c-ea83-e053-2a95a90ae57a2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5918-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
unii: 04JA59TNSJ
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5916-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
unii: 04JA59TNSJ
ALLERGY MULTISYMPTOMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e9ab8e-2252-180d-e053-2a95a90a788f2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
COLD PLUS HEAD CONGESTION SEVEREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART3430c7e4-e142-407e-bed5-358dd6bd10f72024-10-17WarningsExact identifier
unii: 04JA59TNSJ
COLD MAXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa1aba467-c91f-4812-b0b9-ff5fdfa298e32024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dd12f1-dd63-27ae-e053-2995a90aaaeb2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
COLD and FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe44ac549-3e9b-4271-a2b2-ecb124f798322024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTf171a389-8b22-429c-86bc-272156fdc1b72024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART6c5b5427-e47a-4eff-928a-c891452facf92024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20baef9-6e68-6679-e053-2a95a90a2b632024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20b71fb-8787-c871-e053-2a95a90a8eb42024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20bc492-fed3-bf05-e053-2a95a90ad3932024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Head Congestion plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI1db914d3-8bba-405e-9bf9-9b1a5806284c2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.e2c35fae-9dd6-51f2-e053-2995a90a1e9e2024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Cough and Cold XL3 XtraACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.da5b31dd-becd-471a-9392-d0ee4b8f95392024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMIDWAY IMPORTING INC.58252f15-485c-3061-e053-2a91aa0a23202024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMidway Importing, Inc.e41b9beb-e274-5c02-e053-2995a90ad0f82024-10-17WarningsExact identifier
unii: 04JA59TNSJ
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC38e70a28-eff2-4a48-b829-8cd68e80beef2024-10-17WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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