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 210 of 317 · 6,339 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berry Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f128054-4c57-8055-e063-6294a90adc4e2025-01-17WarningsExact identifier
unii: 3K9958V90M
SANI-CLAWSANI-CLAWHomeland Industrial Supply2be875a1-0e9d-2e2a-e063-6394a90a15202025-01-17WarningsExact identifier
unii: 3K9958V90M
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxcc0e654d-1eaa-7d17-e053-2995a90ab1db2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
unii: PDC6A3C0OX
Percogesic Original StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLMedtech Products Inc.529974c2-0121-4892-8e47-c2c4475810912025-01-17WarningsExact identifier
unii: 362O9ITL9D
Kroger DayTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Co.2499210b-c162-76b9-e063-6294a90adbc32025-01-17WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb9df47cf-f999-49d8-95b9-374c0539b6a12025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Little Remedies Childrens Fever Pain RelieverACETAMINOPHENMedtech Products Inc.e1e44c85-d10c-4997-8f85-064cda7906eb2025-01-17WarningsExact identifier
unii: 362O9ITL9D
Kroger NightTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Co.24a73de3-e9eb-4cd4-e063-6394a90aa2632025-01-17WarningsExact identifier
unii: 362O9ITL9D
Dye Free Childrens AcetaminophenACETAMINOPHENPrecision Dose Inc.5cc698fa-0841-4851-ae21-0aac8b40eb0a2025-01-16WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRITE AIDd1f18c32-c043-7c97-e053-2a95a90a203e2025-01-16WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESUNRISE PHARMACEUTICAL, INCee7630f8-f4b8-4eb0-b34d-d908567030c42025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Children Pain and Fever RelieverACETAMINOPHENTarget Corporation0dd643a4-3cbc-423d-95b4-ba373b09d8952025-01-16WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENReliable 1 Laboratories LLC2651bf11-4d66-43ba-e054-00144ff88e882025-01-15WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
unii: 362O9ITL9D
Beautyturess Collagen Moisturizing Firming 14-Piece SetBEAUTYTURESS COLLAGEN MOISTURIZING FIRMING 14-PIECE SETGuangdong Bisutang Biotechnology Co., Ltd.2bc94a8a-effb-8319-e063-6394a90a535d2025-01-15WarningsExact identifier
unii: PDC6A3C0OX
CombogesicACETAMINOPHEN AND IBUPROFENHikma Pharmaceuticals USA Incb32651c4-7fa0-415b-91eb-854aa1c28f2a2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.1e932a34-a7d3-e4ec-e063-6294a90a25b12025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
unii: 362O9ITL9D
ROAME Moisturizing Hand Sanitizer Cloud 999ALCOHOL HAND SANITIZERRoame LLC2bb1003e-8e4c-8dd8-e063-6294a90ad37d2025-01-14WarningsExact identifier
unii: 3K9958V90M
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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