FDA.reportPublic FDA data

NDC 67296-2201-01 - 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
67296-2201
Requested NDC
67296-2201-01
Package NDCs from labels
67296-2201-1, 67296-2201-2, 67296-2201-3, 67296-2201-4, 67296-2201-5, 67296-2201-6, 67296-2201-7, 67296-2201-8, 67296-2201-01
Manufacturer
Redpharm Drug
Effective date
2026-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocodone Bitartrate and Acetaminophen - Redpharm DrugRedpharm Drug2026-03-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2201-1Hydrocodone Bitartrate and Acetaminophen4 in 1 BOTTLETABLET42
67296-2201-2Hydrocodone Bitartrate and Acetaminophen6 in 1 BOTTLETABLET62
67296-2201-3Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET102
67296-2201-4Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET152
67296-2201-5Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET202
67296-2201-6Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET302
67296-2201-7Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET402
67296-2201-8Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET122

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 48 of 182 · 3,632 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
unii: 362O9ITL9D
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3dd21aaf-13b2-9e81-e063-6294a90afaec2026-02-11WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENTopco Associates, LLC2e31fe65-5f50-455b-99fa-c72879f435452026-02-10WarningsExact identifier
unii: 362O9ITL9D
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC869e950c-5861-4840-aaad-b0342790d62b2026-02-10WarningsExact identifier
unii: 362O9ITL9D
CareOne Night TIme Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de252026-02-10WarningsExact identifier
unii: 362O9ITL9D
Pain Relief ChildrensACETAMINOPHENAmerisource Bergen9ea8bb1f-1924-4430-98bd-f2674d0da7482026-02-09WarningsExact identifier
unii: 362O9ITL9D
good sense pain relief arthritis painACETAMINOPHENL. Perrigo Company236eedd4-6ece-46ce-9ab3-12366d57126b2026-02-09WarningsExact identifier
unii: 362O9ITL9D
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Sportpharm LLCd61df3a4-8ae2-46b1-b322-7f4e04cc1bf92026-02-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd4a61313e-1b48-29df-e063-6394a90a27f02026-02-09WarningsExact identifier
unii: 362O9ITL9D
Sinus Congestion and Pain DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIf3fc270a-92fc-46d5-b187-44e875c3abb92026-02-09WarningsExact identifier
unii: 362O9ITL9D
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.d5c8b248-6d82-4eac-881c-0b9d0a0de8f12026-02-09WarningsExact identifier
unii: 362O9ITL9D
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
equate 8hr arthritis pain reliefACETAMINOPHENWALMART INC.36a0cac6-f5d1-4679-8bef-d52577fc0d572026-02-09WarningsExact identifier
unii: 362O9ITL9D
good sense dual actionACETAMINOPHEN, IBUPROFENSportpharm LLC3f4ade2c-56e0-4aab-910e-73c26546a4d72026-02-06WarningsExact identifier
unii: 362O9ITL9D
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEGeiss, Destin & Dunn Inc.bf85fb32-66d4-4683-be9d-58ca4e9f272d2026-02-06WarningsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENA-S Medication Solutionsfc61200e-cc40-47c4-8792-c939c9877ae22026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 857002
unii: NO70W886KK
unii: 362O9ITL9D
Severe Allergy And Sinus Headache Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacyb3c744b8-aa93-505d-f8cf-07995da4283d2026-02-06WarningsExact identifier
unii: 362O9ITL9D
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATEWinCo Foods, LLC911e6a51-c0f0-491a-b70c-00011ed5e35b2026-02-06WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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