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 164 of 318 · 6,358 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer(CHERRY)HAND SANITIZER(CHERRY)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6cc842-8b54-9a27-e063-6294a90a1dd52025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(PEACH)HAND SANITIZER(PEACH)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6bf6be-5328-8151-e063-6294a90a82112025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(COCONUT)HAND SANITIZER(COCONUT)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6ca090-98d9-4650-e063-6294a90a35c02025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer(MANGO)HAND SANITIZER(MANGO)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6c79b9-d4b1-bbaf-e063-6394a90a11002025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Matcha MoodALCOHOLScent Theory Products LLC3f8fc09d-863d-0c13-e063-6394a90a49682025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Ocean MistALCOHOLScent Theory Products LLC3f8fd236-e413-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Sunrise CitrusALCOHOLScent Theory Products LLC3f8fd236-e415-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Velvet VanillaALCOHOLScent Theory Products LLC3f8fdb54-2e2c-2cab-e063-6394a90a1f092025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Sun-Kissed MelonALCOHOLScent Theory Products LLC3f8fe3c4-1373-b45a-e063-6294a90ae05b2025-09-24WarningsExact identifier
unii: 3K9958V90M
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
unii: 3K9958V90M
Smart Care WATERMELON HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.dd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b2025-09-24WarningsExact identifier
unii: 3K9958V90M
Xpect Pain Away Extra StrengthACETAMINOPHEN ASPIRIN CAFFEINECintas Corporation1269d069-afaf-4ca5-b369-f74249a348db2025-09-24WarningsExact identifier
unii: 362O9ITL9D
First Aid Direct Hand SanitizerHAND SANITIZERCintas Corporationdad0fc5d-4a48-4db1-b423-558c2958750c2025-09-24WarningsExact identifier
unii: 3K9958V90M
AcetaminophenACETAMINOPHENProPharma Distribution3f7a6fdc-6e36-dc3e-e063-6394a90a067d2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tendersant Hand SanitizerALCOHOLGeri-Gentle Corporationb09d568a-4c9d-5804-e053-2a95a90ab8ea2025-09-23WarningsExact identifier
unii: 3K9958V90M
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
unii: 362O9ITL9D
Smart Care VANILLA SUGAR HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bad645e8-4f99-4629-9259-9ae856e16d302025-09-22WarningsExact identifier
unii: 3K9958V90M
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
unii: 362O9ITL9D
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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