FDA.reportPublic FDA data

NDC 00121-504 - 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
00121-504
Manufacturer
Rebel Distributors Corp.
Effective date
2010-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen and Codeine Phosphate - Rebel Distributors Corp.Rebel Distributors Corp.2010-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
AcetaminophenACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
CodeineACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
AlcoholINACTIVE INGREDIENT3K9958V90MACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
SucroseINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]1

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 267 of 314 · 6,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL and ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENQUAGEN PHARMACEUTICALS LLC1f0dbe62-6aea-4323-ad25-c2211f9192532024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC24813ec6-0111-4782-9182-a2b93501a2bc2024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBaxter Healthcare Corporation0f67c1bd-915b-4681-88dd-22f5154a80b32024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Basic Care Childrens Pain and FeverACETAMINOPHENAmazon.com Services LLCbf8bed5d-7dd4-492c-98ac-c36ff8be8f412024-05-06WarningsExact identifier
unii: 362O9ITL9D
Basic Care Childrens Pain and FeverACETAMINOPHENAmazon.com Services LLC0c133707-a8b8-4105-82f3-e3855ec196172024-05-06WarningsExact identifier
unii: 362O9ITL9D
leader infants pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leadercfbb8553-f3ac-437d-8f63-caa93f257a772024-05-06WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL and ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENQUAGEN PHARMACEUTICALS LLC2eb09253-7f59-401e-afbc-70bb9600fedf2024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
good sense childrens pain and feverACETAMINOPHENL. Perrigo Companyab96395c-a19e-40d6-b37e-7f988026fc952024-05-06WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWALGREEN CO.c20d110a-ed5e-aed4-e053-2a95a90a42002024-05-06WarningsExact identifier
unii: 362O9ITL9D
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger1014da86-3a0e-136f-e063-6294a90ac9312024-05-04WarningsExact identifier
unii: 362O9ITL9D
Theraflu-D Flu Relief Max Strength plus Nasal DecongestantACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCe35cb719-9e7d-4b2b-81a4-29e147dd74fa2024-05-03WarningsExact identifier
unii: 362O9ITL9D
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLC09e20842-2b75-43b9-ae5f-3515b35e655b2024-05-03WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)f958d8ba-ede9-4b1a-8317-2404b68a91292024-05-03WarningsExact identifier
unii: 362O9ITL9D
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
Tork Hand Sanitizer Alcohol GelETHYL ALCOHOLEssity Professional Hygiene North America LLC9595a664-b7d5-d726-e053-2995a90a20432024-05-02WarningsExact identifier
unii: 3K9958V90M
Pacific Blue Select Gel Hand Sanitizer Fragrance and Dye FreeETHYL ALCOHOLGeorgia-Pacific Consumer Products5bb3a32b-dc2e-4d0c-8a2d-25c278097fee2024-05-02WarningsExact identifier
unii: 3K9958V90M
Pacific Blue Select Foam Hand Sanitizer, Fragrance Free, Dye FreeETHYL ALCOHOLGeorgia-Pacific Consumer Productsf5f21c28-253a-42c4-84f3-34d72f73c9ca2024-05-02WarningsExact identifier
unii: 3K9958V90M
Pacific Blue Basic Gel Hand Sanitizer with MoisturizersETHYL ALCOHOLGeorgia-Pacific Consumer Products51fa26fd-24c5-4bd4-bfe8-8d1a733f1eac2024-05-02WarningsExact identifier
unii: 3K9958V90M
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a2024-05-01WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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