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 20 of 156 · 3,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineACETAMINOPHENMedline Industries, LPfc5e6f2a-e813-0666-e053-6394a90a66a72026-06-04WarningsExact identifier
unii: 362O9ITL9D
MedlineACETAMINOPHENMedline Industries, LPfc5d92c2-4bbe-8ad1-e053-6294a90a65b62026-06-04WarningsExact identifier
unii: 362O9ITL9D
acetaminophenACETAMINOPHENUnit Dose Solutions, Inc.537219ac-552a-a30e-e063-6394a90aa9d12026-06-04WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEUnit Dose Solutions, Inc.537245e8-5e2a-c3e0-e063-6394a90ac8582026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040419
rxcui: 993781
unii: GSL05Y1MN6
unii: 362O9ITL9D
dual pain relieverACETAMINOPHEN, IBUPROFENMeijer, Inc.db1dc4f6-23ec-4a04-baa8-ffa739bce76a2026-06-04WarningsExact identifier
unii: 362O9ITL9D
DUAL ACTIONACETAMINOPHEN, IBUPROFENAmazon.com Services LLC20fe6b3f-e5a6-47d4-a371-9172408fbc462026-06-04WarningsExact identifier
unii: 362O9ITL9D
Pain Relief childrensACETAMINOPHENCVS PHARMACYff878f56-125a-4de7-b063-029f7030733d2026-06-04WarningsExact identifier
unii: 362O9ITL9D
acetaminophen and ibuprofenACETAMINOPHEN, IBUPROFENKroger Companye6c0cca6-812e-4bea-86b0-e15b10f3f0d42026-06-04WarningsExact identifier
unii: 362O9ITL9D
topcare dual actionACETAMINOPHEN, IBUPROFENTopco Associates LLCdddc04c4-d500-4d42-8406-89f27a9ad6512026-06-04WarningsExact identifier
unii: 362O9ITL9D
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIae3114c3-8cfe-4b81-8ac7-c281fe68b4622026-06-03WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCOSTCO WHOLESALE CORPORATION3745aa18-a711-43ed-9bc4-1f087b3c53c02026-06-03WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWalgreen Companyde4e8af4-d3d0-44b3-aea3-79016803ccdc2026-06-03WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENWalgreen Company0b1bef50-7957-4ea1-9ae3-91f59ea2dbb42026-06-03WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.42310898-cf3a-4ffb-88bb-b8b84449156e2026-06-02WarningsExact identifier
unii: 362O9ITL9D
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
unii: 362O9ITL9D
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATECardinal Health 107, LLCa9130f36-4761-4e6b-a383-eca3db06ea932026-06-02WarningsExact identifier
unii: GSL05Y1MN6
GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEFACETAMINOPHENAmerisource Bergenae07a064-fdbd-4bb4-8252-9c122bf3dd812026-06-02WarningsExact identifier
unii: 362O9ITL9D
PAIN RELIEFACETAMINOPHENMeijer, Inc.1319bab8-8f17-44fb-9d91-099b0ba38a8d2026-06-01WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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