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 254 of 314 · 6,263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Cold Flu Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens04defcf6-e20e-402b-b725-d9394a0146b12024-07-16WarningsExact identifier
unii: 362O9ITL9D
Basic Care severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC924bf427-b054-46af-b341-ff162946cd582024-07-15WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Cold TabsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEJHK DBA American Safety & First Aide7d4fe9a-eb09-4266-90c9-290f61ce6ad02024-07-15WarningsExact identifier
unii: 362O9ITL9D
b.pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.bc35f9ec-e453-4994-91ae-2294d058e45d2024-07-12WarningsExact identifier
unii: 3K9958V90M
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
b.pure Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.e0ed1b57-2d7e-4e63-96f5-dbbb2aef26df2024-07-12WarningsExact identifier
unii: 3K9958V90M
b.pure Hand Sanitizer Green Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.7c870d8f-c298-4469-b6d1-f318f6adfd262024-07-12WarningsExact identifier
unii: 3K9958V90M
Ecolab FaciliproALCOHOLEcolab Inc.87aa66da-bbc7-4d02-851b-63c19e68578a2024-07-12WarningsExact identifier
unii: 3K9958V90M
Nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1cf3064d-4ddd-63b9-e063-6294a90aa5472024-07-11WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAmerican Health Packaging03c9ff0d-46e8-448c-944a-7ad59d1afd6d2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb80b88e1-e35c-47de-89ee-314d6054f4ce2024-07-10WarningsExact identifier
unii: 3K9958V90M
ANTISEPTIC HAND SANITIZERETHYL ALCOHOLInnovation Specialties Inc89af8a07-49cd-4b51-9ca7-016f849d7b702024-07-10WarningsExact identifier
unii: 3K9958V90M
5253 hand sanitizerETHYL ALCOHOLInnovation Specialties3ef15fec-bb7a-424a-a361-88a8f9503b5f2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc9bef34b7-fdd0-41ee-a140-ea82552aab472024-07-10WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc7824f5c7-3650-490f-92cd-46c8ec32d7be2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc5849d19f-5761-4500-9596-e705b78f14ae2024-07-10WarningsExact identifier
unii: 3K9958V90M
5406 hand sanitizerETHYL ALCOHOLInnovation Specialties8d83b133-1240-4ec8-9fca-e4cbb84f6caf2024-07-10WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb2eee632-5a1d-4df5-99c8-8ceb3d644c942024-07-10WarningsExact identifier
unii: 3K9958V90M
5259 HAND SANITIZERETHYL ALCOHOLInnovation Specialties3923fe13-0e57-406a-afb9-3e9cef263dab2024-07-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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