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 41 of 69 · 1,365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Multi Symptom Cold Very BerryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS2a849ae9-338f-4642-e063-6394a90a1ca42025-01-17WarningsExact identifier
unii: 04JA59TNSJ
DAY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION2b941963-8a8c-4148-e063-6294a90a1dfb2025-01-13WarningsExact identifier
unii: 04JA59TNSJ
good sense daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company5ddf3283-94e4-465d-842a-471ee946c3302025-01-10WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
unii: 04JA59TNSJ
Drs. pharmacy HEMORRHOIDAL COOLINGPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACYd6f6b482-d85d-001c-e053-2995a90ad98c2025-01-09WarningsExact identifier
unii: 04JA59TNSJ
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: 04JA59TNSJ
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
unii: 512OYT1CRR
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
unii: 512OYT1CRR
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLStrategic Sourcing Servicese416982f-6cbb-4f48-a215-16bea8393dad2025-01-07WarningsExact identifier
unii: 04JA59TNSJ
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
unii: 04JA59TNSJ
DAYTIME COLD AND FLU MULTI SYMPTOMDAYTIME COLD AND FLU MULTI SYMPTOMTARGET CORP9dea350d-2f09-b944-e053-2995a90a2b632024-12-30WarningsExact identifier
unii: 04JA59TNSJ
Pediacare Childrens Cough and Cold GrapeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHfabafdc1-9dd8-4258-af49-bab1e29ad1092024-12-30WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store Products, Inc.ef6836fa-d104-d7b3-e053-2a95a90af2b82024-12-30WarningsExact identifier
unii: 04JA59TNSJ
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
unii: 04JA59TNSJ
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDECivica, Inc.7a23ed28-3912-4398-b660-bf9ec3ee39262024-12-26Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
unii: 04JA59TNSJ
BLISS GVS HEMORRHOIDALPHENYLEPHRINE HCLBliss GVS Pharma Limitedfceea303-2ea0-10e9-e053-6294a90a54922024-12-21WarningsExact identifier
unii: 04JA59TNSJ
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
unii: 04JA59TNSJ
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELPharmacy Value Alliance, LLC7276aab8-0297-2a55-e053-2a91aa0a8d212024-12-20WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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