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 70 of 321 · 6,406 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Cold Plus Flu Plus Chest CongestionACETAMINOPHEN, GUAIFENESINKenvue Brands LLC4e60e1ad-4ad4-c329-e063-6294a90ab3182026-04-08WarningsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eeedd3e-d4b4-9967-e063-6394a90abf332026-04-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eef33c2-695a-3a32-e063-6394a90a0a7b2026-04-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Licensed Hand Sanitizer Squishmallows PinkALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eefc5bc-7dd4-e4c8-e063-6394a90a9a512026-04-08WarningsExact identifier
unii: 3K9958V90M
RubbingETHYL ALCOHOLPerrigo Direct, Incba2266d7-da25-495a-b035-97e149551c302026-04-08Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact identifier
unii: 362O9ITL9D
MidolACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATENavajo Manufacturing Company Inc.cabd10f2-a91e-4406-9249-915e306c867b2026-04-08WarningsExact identifier
unii: 362O9ITL9D
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINENavajo Manufacturing Company Inc.4efbd21b-92fe-96a7-e063-6294a90ac4ad2026-04-08WarningsExact identifier
unii: 362O9ITL9D
Smart Care Licensed Hand Sanitizer Squishmallows PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efeb523-0a73-2e48-e063-6394a90aac5e2026-04-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Licensed Hand Sanitizer Hot Wheels RedALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efefd07-c1df-695a-e063-6294a90a51eb2026-04-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Licensed Hand Sanitizer Hot Wheels PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eff601c-7bcd-1ddd-e063-6294a90a80402026-04-08WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Ocean BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4effb28e-fa83-5a06-e063-6394a90aa2f52026-04-08WarningsExact identifier
unii: 3K9958V90M
Menstrual Pain Relief Maximum Strength / Multi SymptomACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEDOLGENCORP, LLCd441088b-fb1d-4fdc-954f-032f3122212f2026-04-08WarningsExact identifier
unii: 362O9ITL9D
MIGRAINE FORMULAACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer, Inc.529b6ee6-043c-430a-b2e1-b63c81f102912026-04-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack092f4694-98df-41bd-b37c-afbcda087e562026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC1b164780-ec84-4187-8afa-6f8a0da550fc2026-04-07WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
unii: 362O9ITL9D
XtraCare Hand Sanitizer Antibacterial Moisturize with Vitamin E and AloeALCOHOLRejoice Industries Canada Inc.28804477-c19d-4ace-93fe-a400f3bb45f12026-04-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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