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 253 of 314 · 6,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATECare One (Retail Business Services, LLC.)a9a5b39d-b4c8-414e-8fe7-4c0601f751972024-08-05WarningsExact identifier
unii: 362O9ITL9D
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
unii: 362O9ITL9D
FaciliproETHYL ALCOHOLEcolab Inc.71f2504a-2da3-4273-9603-47e4cf64ad242024-08-01WarningsExact identifier
unii: 3K9958V90M
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
unii: 362O9ITL9D
WhiskCare 375 Fragrance FreeALCOHOLWhisk Products, Inc.c6787b12-ab90-4305-a6cc-55fd2c57cd2d2024-07-26WarningsExact identifier
unii: 3K9958V90M
Shimmy Original Hand SanitizerALCOHOLShimmy Products LLCc4c135ed-3b6a-69c8-e053-2a95a90aad1c2024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Rose Hibiscus Hand SanitizerALCOHOLShimmy Products LLCc50b5044-31fd-672a-e053-2995a90a49fc2024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Meyer Lemon Hand SanitizerALCOHOLShimmy Products LLCc50b9543-e276-9052-e053-2a95a90a83252024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Neutral Hand SanitizerALCOHOLShimmy Products LLCdf2761b9-0fca-5e2a-e053-2a95a90a9b8d2024-07-25WarningsExact identifier
unii: 3K9958V90M
8 Hour Pain ReliefACETAMINOPHENAMERISOURCE BERGEN9ab903aa-7170-460b-9527-e3df223f5f552024-07-24WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.1e01f923-38c1-9b59-e063-6394a90a22f12024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP92c22593-daf9-20a8-e053-2a95a90a365d2024-07-23WarningsExact identifier
unii: 362O9ITL9D
Symmetry Foaming Hand SanitizerALCOHOLBuckeye International, Inc.bcab4842-50ff-4c7f-8b85-0126f4b585b02024-07-23Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Altra Hand Sanitizer with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a2974445-eaa3-d9f0-e053-2995a90a78fc2024-07-23WarningsExact identifier
unii: 3K9958V90M
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.4872dfdd-0df6-47ae-87f2-8049191cd4822024-07-18WarningsExact identifier
unii: 362O9ITL9D
LAVENDER SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.5c27f212-4010-44de-9e9d-758ffdfcc5c12024-07-18WarningsExact identifier
unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Incb3c59433-a4cd-42cb-9492-fcdc19ca765c2024-07-18WarningsExact identifier
unii: 3K9958V90M
COCONUT SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.2fa53710-c084-48e0-8300-511d0d93a88d2024-07-18WarningsExact identifier
unii: 3K9958V90M
pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLPublix Super Markets Inc42d271b7-b45f-4497-8de2-4e05b4bebfa92024-07-17WarningsExact identifier
unii: 362O9ITL9D
basic care acetaminophen pmACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC64a0084a-e29e-4c1a-8704-13a3e1238f762024-07-17WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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