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 184 of 317 · 6,339 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
unii: 362O9ITL9D
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTC37e939c6-064b-3548-e063-6294a90a337d2025-06-19WarningsExact identifier
unii: 362O9ITL9D
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sweet Orange Bergamot and AloeETHYL ALCOHOLALO New York LLC31cecf1e-1d6b-0033-e063-6294a90a7b8e2025-06-18WarningsExact identifier
unii: 3K9958V90M
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
unii: 362O9ITL9D
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
unii: 362O9ITL9D
B-Pure Moisturizing Hand Sanitizer, Brazilian Caramel ScentedALCOHOLFourstar Group USA, Inc.30aaedbb-ffb9-4d00-a763-d5444074deb22025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Champagne ScentedALCOHOLFourstar Group USA, Inc.52c0f174-3c4d-4e81-91c5-f2c76bffc5302025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Cherry Pie ScentedALCOHOLFourstar Group USA, Inc.89d8771b-e6eb-4a09-9d06-8c7a692243bd2025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Confetti Cake ScentedALCOHOLFourstar Group USA, Inc.4e87ec93-7e9b-4a6e-8286-93dc1e75c2f52025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Jasmine Dragon Fruit ScentedALCOHOLFourstar Group USA, Inc.144da5c7-45e9-4980-a61c-81c3b9d8e7872025-06-17WarningsExact identifier
unii: 3K9958V90M
Alco Hand SanitizerALCOHOLWoodbine Products Company3bd696e2-9125-4604-ace9-d931d9fb5ea32025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Peach ScentedALCOHOLFourstar Group USA, Inc.340879c5-4a51-44ca-9b28-9f24a1111efd2025-06-17WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Strawberry Cake ScentedALCOHOLFourstar Group USA, Inc.d4db52eb-d207-410e-bcc0-08a97eb141cc2025-06-17WarningsExact identifier
unii: 3K9958V90M
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAarkish Pharmaceuticals NJ Inc.82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a62025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Smart Care CARAMEL HONEY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.ffd8dfae-3205-455d-8bbe-9e9f8ee859e12025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET CITRUS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5bcc5f69-713c-45c5-aa19-6a1086c71c352025-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care JUICY BERRY HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.8f9feca1-59e9-4be9-9b89-0a615be159ef2025-06-16WarningsExact identifier
unii: 3K9958V90M
migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer Distribution Inc8f1ee554-1021-4613-ba0e-aa02f8a751f82025-06-16WarningsExact identifier
unii: 362O9ITL9D
Smart Care PISTACHIO BRULE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.3a88b38c-f754-4756-be73-e1c03fe607302025-06-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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