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 259 of 314 · 6,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Sweet Cinnamon PumpkinALCOHOLBath & Body Works, Inc.1ba62d80-58ed-ef58-e063-6294a90ac36d2024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunlit Palm TreesALCOHOLBath & Body Works, Inc.1ba628e9-6abb-89a1-e063-6394a90aa5bc2024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel TropidelicALCOHOLBath & Body Works, Inc.1ba62cc3-020c-d3f8-e063-6394a90ac16a2024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Orange BlossomALCOHOLBath & Body Works, Inc.1ba6082b-42cb-e7de-e063-6294a90a993d2024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Wisteria GardenALCOHOLBath & Body Works, Inc.1ba69e52-2b70-6d06-e063-6394a90a69232024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Turquoise WatersALCOHOLBath & Body Works, Inc.1ba6982d-6822-50ed-e063-6394a90a6ac92024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vampire BloodALCOHOLBath & Body Works, Inc.1ba67404-fecc-b089-e063-6394a90a20d92024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Wildberry French ToastALCOHOLBath & Body Works, Inc.1ba6a663-9590-4f80-e063-6294a90ac1dd2024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and VanillaALCOHOLBath & Body Works, Inc.1ba6a8d8-b081-bd38-e063-6294a90a44c22024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.1ba6a544-2748-68ff-e063-6394a90a63c32024-06-24WarningsExact identifier
unii: 3K9958V90M
STAYKLEARALCOHOLeHealth Nexus LLCc8b31580-5672-61de-e053-2995a90a3e782024-06-24WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Vanilla Sugar Cookie ScentedALCOHOLFOURSTAR GROUP USA, INC.162a9382-134f-42c1-8961-bcb281be282c2024-06-24WarningsExact identifier
unii: 3K9958V90M
b pure Hydrating Hand Sanitizer Frosted Coconut ScentedALCOHOLFOURSTAR GROUP USA, INC.dd57d7fa-deb3-4b02-a9cc-a39153afa0492024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Love Always WinsALCOHOLBath & Body Works, Inc.1b6a8105-53d2-8e0f-e063-6394a90a64af2024-06-21WarningsExact identifier
unii: 3K9958V90M
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.9e4024f4-0f60-dfef-e053-2995a90ac3662024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINNuCare Pharmaceuticals,Inc.9e691264-d48a-6b48-e053-2995a90a93522024-06-20WarningsExact identifier
unii: GSL05Y1MN6
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.925f9787-3d1c-0189-e053-2a95a90a29722024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.b3a06e4b-0b31-4e2a-8dd1-9de85760477b2024-06-19WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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