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 219 of 317 · 6,339 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eZFoam Foaming Alcohol Hand SanitizerFOAMING HAND SANITIZERKutol Products Company1f56b4c5-d703-4193-83a8-3be815c8acda2024-12-18WarningsExact identifier
unii: 3K9958V90M
Santi-Gel Instant Hand SanitizerSANTI-GEL INSTANT HAND SANITIZERKutol Products Company, Inc.f5bb2593-e036-4586-a807-2049e06b24752024-12-18WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
unii: 3K9958V90M
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
unii: 3K9958V90M
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
unii: 3K9958V90M
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.91e50642-d278-47c6-944b-4ed907e87e6b2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLNatures Formulae Health Products Ltd.a7da75b3-b55d-641c-e053-2995a90a43b72024-12-17WarningsExact identifier
unii: 3K9958V90M
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
unii: 362O9ITL9D
Foster and Thrive Decolorized IodineALCOHOL LIQUIDStrategic Sourcing Services, LLC2981529a-2bd0-3e9e-e063-6294a90a72362024-12-17WarningsExact identifier
unii: 3K9958V90M
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
unii: 362O9ITL9D
PURELL VF PLUS Hand Sanitizer GelALCOHOLGOJO Industries, Inc.788a154e-f32f-410f-8648-f0bbd0772e662024-12-16WarningsExact identifier
unii: 3K9958V90M
SAN X E3ALCOHOLAmerisan, LLCd6e219a6-f4d6-b8df-e053-2995a90a58032024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Moisturizing 2in1 FoamALCOHOLGOJO Industries, Inc.19d4a358-74e0-4333-ace9-ed8b4ce729992024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer ULTRA NOURISHING FoamALCOHOLGOJO Industries, Inc.333246ca-9420-44c9-9240-37a9cdc03e2b2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Naturals FoamALCOHOLGOJO Industries, Inc.0b881323-938b-405f-beb2-0875256d37222024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer PRIME DEFENSEALCOHOLGOJO Industries, Inc.9962349e-ed78-4b22-be00-e38ab0c55dfe2024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP Lavender and VerbenaALCOHOLGOJO Industries, Inc.6a17d905-a55e-413c-b2af-0b06bf0d35c32024-12-16WarningsExact identifier
unii: 3K9958V90M
PURELL Hand Sanitizer SP UnscentedALCOHOLGOJO Industries, Inc.f87058df-2efd-4ea8-ae37-35e472bd091f2024-12-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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