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 41 of 183 · 3,648 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
unii: 362O9ITL9D
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
GOOD SENSE TUSSINACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company5fb96638-a9bc-4be6-a624-da303a9e98a32026-03-25WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Relief Multi symptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC9beeeb3b-6b26-4b9a-843b-ce3658d1debe2026-03-25WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1d63d261-bdd4-4951-b8aa-09561e5b19fc2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefNIGHTTIME COLD AND FLU RELIEFGrocery Outleta58459e3-6ada-4d99-9e22-1a01076761512026-03-25WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack09db348f-8396-41b2-b639-608dcfdbccf42026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)804d4b63-1bbe-47c0-ad49-39ddbeade6a32026-03-25WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGGrocery Outlet2f90dfb6-4257-44a8-a685-1873645d1c962026-03-25WarningsExact identifier
unii: 362O9ITL9D
good sense childrens pain and feverACETAMINOPHENPreferred Pharmaceuticals Inc.b5971407-2d95-4edb-88fe-0bd82d9116832026-03-25WarningsExact identifier
unii: 362O9ITL9D
childrens pain and feverACETAMINOPHENHyVee Inc9d9c2bf6-8660-4987-8794-936d3102da8d2026-03-24WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4d887ed0-4532-5125-e063-6394a90ac44d2026-03-24WarningsExact identifier
unii: 362O9ITL9D
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS HEALTH CORP2ba90b91-2e35-4701-e063-6294a90a75542026-03-24WarningsExact identifier
unii: 362O9ITL9D
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Severe Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLCb7b1c3cc-fdf3-4e75-8c3f-2e832f09a8872026-03-24WarningsExact identifier
unii: 362O9ITL9D
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCed28bfa9-3768-4f42-ae5e-1c527b4456d12026-03-24WarningsExact identifier
unii: 362O9ITL9D
Sinus Severe DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCb65baa7c-8197-4361-b3ef-e60eba38dca12026-03-24WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain RelieverACETAMINOPHENBJWC (Berkley & Jensen / BJ's)851228ea-eaf3-452b-a9ce-8cd244a0eaf32026-03-24WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Congestion and Headache Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2638b541-e680-4949-a7c7-fcee165cbc922026-03-23WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackdb14e63a-8e3e-4524-b45a-cb09f705f73a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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