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 263 of 314 · 6,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Champagne Apple and HoneyALCOHOLBath & Body Works, Inc.1a252344-cf76-752e-e063-6294a90a010f2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Chasing DaydreamsALCOHOLBath & Body Works, Inc.1a25aac4-34f8-0371-e063-6294a90ac0822024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Coffee and WhiskeyALCOHOLBath & Body Works, Inc.1a25de73-8740-c98d-e063-6394a90afffb2024-06-05WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Crystal Blue CoastALCOHOLBath & Body Works, Inc.1a25f084-5228-b3ef-e063-6294a90a98822024-06-05WarningsExact identifier
unii: 3K9958V90M
AcetaminophenACETAMINOPHENBluePoint Laboratoriesc065c531-88f5-0930-e053-2a95a90ae8612024-06-05WarningsExact identifier
unii: 362O9ITL9D
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company126ee71a-c408-415b-9a43-502337a910552024-06-05WarningsExact identifier
unii: 362O9ITL9D
Tylenol Extra StrengthACETAMINOPHENA-S Medication Solutions85294a70-3233-4ba5-bc36-ee3f2964aebf2024-06-05WarningsExact identifier
unii: 362O9ITL9D
Anti Bacterial Hand Gel Brightest BloomALCOHOLBath & Body Works, Inc.1a128ecb-230f-0882-e063-6294a90a41372024-06-04WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Brown Sugar Toaster TreatALCOHOLBath & Body Works, Inc.1a12d9ca-fec4-2adc-e063-6394a90ab1812024-06-04WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel ButterflyALCOHOLBath & Body Works, Inc.1a12dbf3-2d95-291c-e063-6394a90a1efd2024-06-04WarningsExact identifier
unii: 3K9958V90M
acetaminophen for childrenACETAMINOPHENNuCare Pharmaceutiacals,Inc.5d7ef1d2-d970-7b01-e053-2991aa0a13112024-06-04WarningsExact identifier
unii: 362O9ITL9D
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Company0a28a4f1-d947-489b-be28-36ba10b581cf2024-06-01WarningsExact identifier
unii: 362O9ITL9D
Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.dbfdecf0-a961-4cc5-bf87-ae30bbc302dd2024-05-31WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4a873428-bb5a-4e48-9185-2a27f289110d2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack88d05136-7b04-4b25-af1c-6bc72fdbcbd72024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack96173ce4-4836-43ae-9797-5246f830643a2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a6c3c6-4b27-9011-e063-6394a90ae5122024-05-30WarningsExact identifier
unii: 3K9958V90M
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsExact identifier
unii: 3K9958V90M
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3791abd3-fcdf-4c8d-b46d-db6e5c8057702024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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