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 51 of 183 · 3,648 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain RelieverACETAMINOPHENStrategic Sourcing Services, LLC959db1b0-2d9f-4857-b475-0fa0273652122026-01-29WarningsExact identifier
unii: 362O9ITL9D
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Night Time Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLCe7dd763b-3005-4723-933b-171eb772afee2026-01-29WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENFOODHOLD U.S.A., LLCbc19bd47-69ea-4bcc-8d28-c043c9d325132026-01-29WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBrACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd24bc9ae6-8e8f-c0a0-e063-6394a90a407f2026-01-28WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited229d1939-84a9-f18e-e063-6394a90aba302026-01-28WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1fcbafaa-c871-db6d-e063-6394a90aab5e2026-01-28WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1f7a6375-ab66-9782-e063-6394a90a99f32026-01-28WarningsExact identifier
unii: 362O9ITL9D
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.4970b8bc-3c7b-4b8a-e063-6294a90a7f1b2026-01-28WarningsExact identifier
unii: 362O9ITL9D
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENTHE KROGER COb49aae4f-b040-44a0-be73-cdf45cf14d7e2026-01-28WarningsExact identifier
unii: 362O9ITL9D
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b25faa8c-2d13-450a-970f-81c17a6330302026-01-28WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)fe3e74ba-31d9-4d50-ab61-ffb6aaa660852026-01-28WarningsExact identifier
unii: 362O9ITL9D
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leader9b1a5dbe-39dd-4dbb-800c-0cef422ae7c52026-01-28WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company93d5b1db-e9ad-4a6a-b869-fd0d1a11df022026-01-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED37e8ccd5-6be1-9aca-e063-6394a90a52632026-01-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESOFTGEL HEALTHCARE PRIVATE LIMITED2f7f078e-de04-9d53-e063-6394a90a409f2026-01-27WarningsExact identifier
unii: 362O9ITL9D
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWal-Mart Stores Inca88eba4c-0701-4eec-9a24-a804186fbfd82026-01-27WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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