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 40 of 182 · 3,632 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equisetum SiliceaEQUISETUM SILICEAUriel Pharmacy Inc.e88b820b-4a07-42e2-8fe2-b30729e91a8c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
Dr. Simi Daytime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MGFarmacias De Similares TX LLC4e448fd0-cb6b-b69b-e063-6394a90afde82026-03-30WarningsExact identifier
unii: 362O9ITL9D
Dr. Simi Nighttime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MGFarmacias De Similares TX LLC4e5772ee-586c-6191-e063-6294a90a132d2026-03-30WarningsExact identifier
unii: 362O9ITL9D
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
Good Sense Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.7dbd0a2d-8597-4010-bfe2-94a8d145ca572026-03-27WarningsExact identifier
unii: 362O9ITL9D
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: ETJ7Z6XBU4
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCHAIN DRUG MARKETING ASSOCIATION INC7d1b3418-85a8-4ca0-bca7-261b2b58032a2026-03-26WarningsExact identifier
unii: 362O9ITL9D
Childrens AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.68e214cd-2d09-42d0-a4e9-b1b81af6be3c2026-03-26WarningsExact identifier
unii: 362O9ITL9D
Good Sense Childrens Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.a00dc563-6611-46b8-ab5c-1b2c602f3c682026-03-26WarningsExact identifier
unii: 362O9ITL9D
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP2baa0861-dbef-7910-e063-6394a90a117e2026-03-26WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf1a7d87c-866d-4c6d-b9fd-e809b0a217732026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210211
rxcui: 857005
unii: NO70W886KK
unii: 362O9ITL9D
M-PAPACETAMINOPHENBryant Ranch Prepackad01aea6-4af3-469b-b99d-e1e66aa40e8d2026-03-25WarningsExact identifier
unii: 362O9ITL9D
flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRMeijer Distribution Inc1a853e47-21a2-40e1-9e64-290af4843b132026-03-25WarningsExact identifier
unii: 362O9ITL9D
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
unii: 362O9ITL9D
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
application number: ANDA210211
rxcui: 857002
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
application number: ANDA210211
rxcui: 856999
unii: NO70W886KK
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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