FDA.reportPublic FDA data

NDC 46672-166-50 - 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
46672-166
Requested NDC
46672-166-50
Package NDCs from labels
46672-166-10, 46672-166-50
Manufacturer
Mikart, LLC
Effective date
2020-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
hydrocodone bitartrate and acetaminophen - Mikart, LLCMikart, LLC2020-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, 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 65 of 183 · 3,644 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAurolife Pharma, LLC470df63a-5c0f-42df-9023-a330a901153e2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
Sinus PE Head Congestion and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED76fd1f8e-2670-421c-a9e6-c8adefb7962e2025-12-23WarningsExact identifier
unii: 362O9ITL9D
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENGranules USA, Inca1255f60-b9c6-9a95-e053-2995a90a9e802025-12-22WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENGranules USA, Inca51395ea-e038-dc9c-e053-2a95a90a287d2025-12-22WarningsExact identifier
unii: 362O9ITL9D
CareALL AcetaminophenACETAMINOPHENNew World Imports, Inc1148b4d9-fa6a-49e6-9663-17b2c83738462025-12-22WarningsExact identifier
unii: 362O9ITL9D
VitapirenaACETAMINOPHENPharmadel LLC0547bc1f-d000-f5a6-e063-6294a90ac73d2025-12-22WarningsExact identifier
unii: 362O9ITL9D
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Incf818417e-0b31-4fe7-8313-4160a00b248a2025-12-22WarningsExact identifier
unii: 362O9ITL9D
CareALL AcetaminophenACETAMINOPHENNew World Imports, Incc4f82ed8-b82c-47bb-9ab9-108a13d29cf72025-12-22WarningsExact identifier
unii: 362O9ITL9D
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc5103450a-3095-49cc-9823-4fb4c1d258ff2025-12-22WarningsExact identifier
unii: 362O9ITL9D
CAREALL Non-Aspirin PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc499b2bf8-72fb-4500-b16e-517cab09a8ae2025-12-22WarningsExact identifier
unii: 362O9ITL9D
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc933154b9-c9d6-4260-8775-1c83631c74e42025-12-22WarningsExact identifier
unii: 362O9ITL9D
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Incc93aa5e4-3994-439f-8f14-4e81773ed4e22025-12-22WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENGranules USA, Inc.96131c7b-bdff-0642-e053-2a95a90a4f322025-12-22WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLGranules USA, Inc.8c9f68e3-fedc-6457-e053-2995a90a045a2025-12-22WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHarris Teeter, LLC89fd57d2-fe49-41cb-b02e-9643e526cf472025-12-22WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefACETAMINOPHEN, CAFFEINENUVICARE LLCea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e2025-12-19WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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