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 111 of 319 · 6,375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.2453d635-989d-4569-96b3-4efaf61cca712026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
unii: 362O9ITL9D
Smart Care MONSTER JAM SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.6ed35ced-411a-44ad-8c33-fa900e6502542026-01-13WarningsExact identifier
unii: 3K9958V90M
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
unii: 362O9ITL9D
Perk Hand Sanitizer with MoisturizersALCOHOLWorklifebrands LLC4846937f-905e-faec-e063-6394a90a77a22026-01-13WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHANOLSaraya Healthcare30c68860-c7ff-5dbb-e054-00144ff8d46c2026-01-13WarningsExact identifier
unii: 3K9958V90M
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
unii: 362O9ITL9D
Hand SanitizerALCOHOLSaje Natural Business Inc.a70da1c6-4ca6-b801-e053-2a95a90ae1a52026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care CALMING LAVENDER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.88d45355-3578-42bf-8c22-3efcbb99e59a2026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care tokidoki Mermicorno SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.529d13e4-f6b7-4c7a-bb62-094f845b94282026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care COCONUT BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.062fc0fd-a501-411c-baff-0ad4c23cae3e2026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care LEMON LIME HAND SANITIZERETHYL ALCOHOLAshtel Studios, Ince503895d-7b23-4865-90b3-5348faffd45c2026-01-13WarningsExact identifier
unii: 3K9958V90M
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
unii: 362O9ITL9D
Instant Hand SanitizerALCOHOLHydrox Laboratoriesa818def4-f6e9-4a97-aa26-b7c082ae8d182026-01-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHydrox Laboratories285505b0-ee49-4d01-9019-1052e2fb19642026-01-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer UnscentedALCOHOLHydrox Laboratoriescd42da2c-0235-4410-945b-baabb5c7931b2026-01-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLLTC Products Inc.6c16aeec-bef2-41f1-b22d-ac37c36255622026-01-12WarningsExact identifier
unii: 3K9958V90M
Hand Essentials Instant Hand AntisepticETHYL ALCOHOLHu-Friedy Mfg. Co., Inc.a580ebfb-2da9-4a20-9a3c-6244dbb7aef12026-01-12WarningsExact identifier
unii: 3K9958V90M
Epi-Clenz Pure Instant Hand AntisepticETHYL ALCOHOLMedline Industries, LP9f2be060-0699-47ab-9398-efe91eef22672026-01-12WarningsExact identifier
unii: 3K9958V90M
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENBIONPHARMA INC.4834aa7f-cb0c-ec58-e063-6394a90ae2fc2026-01-12WarningsExact identifier
unii: 362O9ITL9D
PURELL Advanced Hand Sanitizer be PeacefulALCOHOLGOJO Industries, Inc.45810c51-8738-4b8a-8d8f-46b4b41dbe932026-01-12WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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