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 218 of 317 · 6,339 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarONE unscentedETHYL ALCOHOLSoaptronic, LLCa6a798bd-09cb-1853-e053-2995a90a27f92024-12-19WarningsExact identifier
unii: 3K9958V90M
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
EXTENDED CARE Foaming Hand SanitizerALCOHOLTRIPLE A SUPPLIES, INC.f244f9c0-82c6-42a8-b0a8-63af546ed26f2024-12-19WarningsExact identifier
unii: 3K9958V90M
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
unii: 3K9958V90M
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cucumber MelonALCOHOLBath & Body Works, Inc.29a63c54-116f-30bb-e063-6394a90a8c6f2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Frosted Coconut SnowballALCOHOLBath & Body Works, Inc.29a652a8-15fd-80d4-e063-6394a90acb4d2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Black Cherry FrostALCOHOLBath & Body Works, Inc.29a654df-016b-830e-e063-6394a90a10622024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Winterberry IceALCOHOLBath & Body Works, Inc.29a64c95-eb54-8081-e063-6394a90a07262024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Magic In The AirALCOHOLBath & Body Works, Inc.29a651e4-a014-57d2-e063-6394a90a35f02024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.29a64de5-af39-5a91-e063-6394a90ac35c2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Honolulu SunALCOHOLBath & Body Works, Inc.29a64c62-8517-1b39-e063-6294a90a35a82024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry SnowflakesALCOHOLBath & Body Works, Inc.29a651e4-a016-57d2-e063-6394a90a35f02024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Snowflakes and CashmereALCOHOLBath & Body Works, Inc.29a654df-0169-830e-e063-6394a90a10622024-12-19WarningsExact identifier
unii: 3K9958V90M
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
unii: 362O9ITL9D
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLC53941807-072e-4783-819d-106ea904eda22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLCe7d36246-9c80-49b6-ad4b-e38c3fd6d0682024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3fe91e9f-4033-4b48-b51b-7eb67d40fa3a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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