FDA.reportPublic FDA data

NDC 63629-5666-01 - ACETAMINOPHEN AND CODEINE PHOSPHATE

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
63629-5666
Requested NDC
63629-5666-01
Package NDCs from labels
63629-5666-1, 63629-5666-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETAMINOPHEN AND CODEINE PHOSPHATE - Bryant Ranch PrepackBryant Ranch Prepack2025-06-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5666-1ACETAMINOPHEN AND CODEINE PHOSPHATE10 in 1 BOTTLETABLET101

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 63 of 155 · 3,094 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b7c7fc-1068-f486-e053-2a95a90a8e8c2025-12-11WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b9e0da-2c54-8b31-e053-2995a90a690b2025-12-11WarningsExact identifier
unii: 362O9ITL9D
Allergy ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company0a6e3251-02e0-42c1-bdf3-51c77f88c17f2025-12-11WarningsExact identifier
unii: 362O9ITL9D
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC516ab016-31f9-4829-8b94-2f968933093c2025-12-11WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC60f43308-1deb-4f05-8f17-aa49ebdcf4982025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma355a094c-bed9-4959-8cf0-619f0e2461052025-12-11WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATEActavis Pharma, Inc.52321fe5-c001-4e2d-8149-3197ddc137642025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
unii: 362O9ITL9D
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACY, INCcf4eb4c4-68e0-4478-a81c-d3d1e66f5cc52025-12-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC2e30754a-42f7-4da2-944c-be61cee47b432025-12-10WarningsExact identifier
unii: 362O9ITL9D
Midol Complete, Travel BASIXACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATELil' Drug Store Products, Incd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca2025-12-10WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.ff1f6f82-0c7c-4e3f-a2bd-3185e16fa7702025-12-10WarningsExact identifier
unii: 362O9ITL9D
Tylenol Cold plus Flu Severe, Lil Drug StoreACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Incf395c196-62d7-47ff-b38d-af37adf5980b2025-12-10WarningsExact identifier
unii: 362O9ITL9D
Tylenol Sinus Severe, Lil Drug StoreACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Inc88b68447-b016-4d5b-a5e3-c4ebccb14f8c2025-12-10WarningsExact identifier
unii: 362O9ITL9D
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAdvanced Rx of Tennessee, LLC45a18fad-ad4e-3a1b-e063-6394a90a23cf2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEActavis Pharma, Inc.ea5b9ffe-3cda-405e-8f75-3fd4a64c9a352025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
good neighbor pharmacy day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergene5c1bd96-d27d-49c1-b3b8-eee53a145ef52025-12-10WarningsExact identifier
unii: 362O9ITL9D
NiteTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe67bf-2c66-61e6-e063-6394a90a7f8f2025-12-10WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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