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 18 of 156 · 3,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLStrategic Sourcing Services LLC067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a62026-06-16WarningsExact identifier
unii: 362O9ITL9D
Equate Severe Cold Cough and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.a35531d7-1a96-45cb-922f-61db085cde1f2026-06-16WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENL.N.K. International, Inc.734cc3d2-6fc5-4dcc-93ed-0b57c1f013452026-06-15WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Sinus CongestionACETAMINOPHEN, PHENYLEPHRINE HCLBetter Living Brands, LLC1d3d6397-0d92-4145-9a70-8bcc45bd03222026-06-15WarningsExact identifier
unii: 362O9ITL9D
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d63671d-cf7c-bbdd-e063-6294a90affef2026-06-15WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENGranules India Limited00eb3e4b-1507-4c9a-83a5-ef50cb3127532026-06-15WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENShield Pharmaceuticals Corp.96eb7f9f-ff2d-4661-bbe6-1860aafe03f62026-06-15WarningsExact identifier
unii: 362O9ITL9D
Duralgina Extra StrengthACETAMINOPHENMenper Distributors, Inc.544e3d7e-a759-384f-e063-6294a90a5baa2026-06-15WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd1cb17-4aea-a750-e063-6394a90a95942026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd2e535-dd11-4bfb-e063-6394a90a9fbc2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3d3292f0-93b5-1fd0-e063-6294a90a37162026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
pain relief childrensACETAMINOPHENRite Aid Corporationbe2286a1-946b-4bf5-b14c-8e86da6695942026-06-15WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESpecGx LLCeadc80fa-13c3-471a-a22f-6fe7e1ab290f2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040419
ndc (product): 0406-0484
rxcui: 993890
rxcui: 993781
rxcui: 993770
spl id: 2c5aeddb-dc8b-4d50-821a-fd9adc26a8f1
spl set id: eadc80fa-13c3-471a-a22f-6fe7e1ab290f
unii: GSL05Y1MN6
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLC55e996cd-ef22-4e09-a05c-8aa994e4540b2026-06-12WarningsExact identifier
unii: 362O9ITL9D
CHILDRENS TYLENOLACETAMINOPHENKenvue Brands LLC3162733b-9382-39f1-e063-6294a90ac4202026-06-12WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9769e0c0-2f4c-3b7a-1a65-c98fbce116812026-06-12WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddfe71cc-27bf-4807-b62f-e6cf982e2dfd2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENNuCare Pharmaceuticals, Inc.54010ddf-25d1-2016-e063-6294a90a877d2026-06-11WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENPreferred Pharmaceuticals Inc.983debdf-4a61-4dde-ba34-567fdd17720e2026-06-11WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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