FDA.reportPublic FDA data

NDC 66689-005-01 - Hydrocodone Bitartrate and Acetaminophen

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
66689-005
Requested NDC
66689-005-01
Package NDCs from labels
66689-005-01, 66689-005-50
Manufacturer
VistaPharm, LLC
Effective date
2024-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocodone Bitartrate and Acetaminophen - VistaPharm, LLCVistaPharm, LLC2024-07-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-005-502024-01-30C16284748780-11030e365-0938-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Oral Solution, CII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-005-01ML - Milliliter66689-0050047ce97-2c9b-4817-adc1-22461f69467e12019-07-02
66689-005-50ML - Milliliter66689-0053bfc0e60-dde1-4375-abfe-cc156f1aae2812019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
Hydrocodone BitartrateACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
AcetaminophenACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
HydrocodoneACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
Ethyl MaltolINACTIVE INGREDIENTL6Q8K29L05HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
MethylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
SorbitolINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
SucroseINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [VISTAPHARM INC.]4

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 127 of 180 · 3,596 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
unii: 362O9ITL9D
up and up infants acetaminophenACETAMINOPHENTarget Corporation31104956-04d7-41b5-82be-219ded5c02a92024-10-30WarningsExact identifier
unii: 362O9ITL9D
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLRite Aid Corporation9a71e8eb-4195-4694-bf3e-44f691ff2cef2024-10-30WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLH E Bfe4a95d2-6fb3-43fe-baec-6f22d19653232024-10-30WarningsExact identifier
unii: 362O9ITL9D
NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger Company2c9ef0d7-3d5b-494a-8f06-9dd42110d78a2024-10-30WarningsExact identifier
unii: 362O9ITL9D
Severe NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacyd40d6fd1-3f84-40ae-ab7e-04569eb416172024-10-30WarningsExact identifier
unii: 362O9ITL9D
Spleenex VHARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.54e2c88e-2483-4c38-86e5-19e218e713ae2024-10-30WarningsExact identifier
unii: XF417D3PSL
equaline nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI4e0c6ad6-81ef-4b0e-b2eb-44256faf73582024-10-30WarningsExact identifier
unii: 362O9ITL9D
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC130e68d1-9048-49c1-beee-490eecaed2d92024-10-30WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company02f3e739-3153-412f-b2cd-6f01dcd5875b2024-10-30WarningsExact identifier
unii: 362O9ITL9D
Spleenex VARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUMEnergique, Inc.effbaa07-239b-42f2-afd4-0eeeba7de1fd2024-10-30WarningsExact identifier
unii: XF417D3PSL
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen5101125d-4819-4e4b-a0ee-a0ff8d5a0ab12024-10-30WarningsExact identifier
unii: 362O9ITL9D
Antigrip FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23a03-6110-f595-e063-6394a90a70fe2024-10-29WarningsExact identifier
unii: 362O9ITL9D
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23e5e-302a-7b7f-e063-6294a90a04632024-10-29WarningsExact identifier
unii: 362O9ITL9D
Antigrip Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPharmadel LLC25a26adf-fd90-bf57-e063-6294a90a40732024-10-29WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEBryant Ranch Prepack5b918d6b-94b0-4f9a-ab09-6a511b727de02024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Careone daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAmerican Sales Company31187c98-6706-4962-91f6-022a390cda392024-10-28WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenPAIN RELIEVERMcKesson9d620700-5d00-475f-e053-2995a90a9a3f2024-10-28WarningsExact identifier
unii: 362O9ITL9D
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC0100f86e-257f-4197-9849-3c4429cdf0f22024-10-28WarningsExact identifier
unii: 362O9ITL9D
LactistatARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALEEnergique, Inc.8dcc4a3a-9f21-4a77-ae42-b2c8283a076a2024-10-28WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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