FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
0121-0504
11-digit product format
001210504
Labeler code
0121
Product ID
0121-0504_850320f4-13d8-38c7-e053-2991aa0a4947
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA087508
Marketing category
ANDA
Marketing start
1981-08-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
120 mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-0504-002023-02-23C16284748780-19d75b9cf-f0b0-f424-e053-dadaa90a57ceAcetaminophen and Codeine Phosphate Oral Solution USP CV
0121-0504-042023-02-23C16284748780-19d75b9cf-f0b0-f424-e053-dadaa90a57ceAcetaminophen and Codeine Phosphate Oral Solution USP CV
0121-0504-122023-02-23C16284748780-19d75b9cf-f0b0-f424-e053-dadaa90a57ceAcetaminophen and Codeine Phosphate Oral Solution USP CV
0121-0504-162023-02-23C16284748780-19d75b9cf-f0b0-f424-e053-dadaa90a57ceAcetaminophen and Codeine Phosphate Oral Solution USP CV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0504-04Acetaminophen and Codeine Phosphate118 mL in 1 BOTTLESOLUTION11831
0121-0504-05Acetaminophen and Codeine Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION531
0121-0504-16Acetaminophen and Codeine Phosphate473 mL in 1 BOTTLESOLUTION47331
0121-0504-40Acetaminophen and Codeine Phosphate40 in 1 CASESOLUTION4031
0121-0504-40Acetaminophen and Codeine Phosphate10 in 1 TRAYSOLUTION1031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0504-00ML - Milliliter0121-0504d7a3f004-ca0c-4f1c-ad5c-6c46275f59eb12017-08-11
0121-0504-04ML - Milliliter0121-0504969a676e-4598-4cc4-aa2f-60d6e59bcbed12012-07-24
0121-0504-05ML - Milliliter0121-0504eea7e525-e9ad-4b1e-878d-c5d4bfef77c112012-07-24
0121-0504-10ML - Milliliter0121-0504b2ee4dd9-3150-43a2-a695-2814f460eb5c12012-07-24
0121-0504-12ML - Milliliter0121-050453d82ab1-3ee7-4a3e-81ef-6cf19e25837e12012-07-24
0121-0504-15ML - Milliliter0121-05043fdc83aa-2edd-43ae-a741-d9a7b3f0187f12012-07-24
0121-0504-16ML - Milliliter0121-05040d39973b-5f07-4967-a63b-610e51a8c86612012-07-24
0121-0504-40ML - Milliliter0121-0504d1ba4a38-dc9d-4a05-b7f2-983aa8550c1912024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
SUCROSEINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0504ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]31Legacy NDC, 5 package rows20241006_95ac6875-6b14-4cde-8efb-80704e39b8d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993755codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral SolutionPSN95ac6875-6b14-4cde-8efb-80704e39b8d831
993755acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral SolutionSCD95ac6875-6b14-4cde-8efb-80704e39b8d831
993755acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral SolutionSY95ac6875-6b14-4cde-8efb-80704e39b8d831
993755acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral SolutionSY95ac6875-6b14-4cde-8efb-80704e39b8d831
993755APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral SolutionSY95ac6875-6b14-4cde-8efb-80704e39b8d831
993755codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral SolutionSY95ac6875-6b14-4cde-8efb-80704e39b8d831
993755codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral SolutionPSNf522eae6-383a-45e9-a077-37780db6b14d5
993755acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral SolutionSCDf522eae6-383a-45e9-a077-37780db6b14d5
993755acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral SolutionSYf522eae6-383a-45e9-a077-37780db6b14d5
993755acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral SolutionSYf522eae6-383a-45e9-a077-37780db6b14d5
993755APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral SolutionSYf522eae6-383a-45e9-a077-37780db6b14d5
993755codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral SolutionSYf522eae6-383a-45e9-a077-37780db6b14d5
993755codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral SolutionPSN616fdb50-ee82-2a80-e053-2991aa0a1a944
993755acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral SolutionSCD616fdb50-ee82-2a80-e053-2991aa0a1a944
993755acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral SolutionSY616fdb50-ee82-2a80-e053-2991aa0a1a944
993755acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral SolutionSY616fdb50-ee82-2a80-e053-2991aa0a1a944
993755APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral SolutionSY616fdb50-ee82-2a80-e053-2991aa0a1a944
993755codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral SolutionSY616fdb50-ee82-2a80-e053-2991aa0a1a944
993755codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral SolutionPSN59c33fd9-ef24-4893-b904-3e5f8cea58c73
993755acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral SolutionSCD59c33fd9-ef24-4893-b904-3e5f8cea58c73
993755acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral SolutionSY59c33fd9-ef24-4893-b904-3e5f8cea58c73
993755acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral SolutionSY59c33fd9-ef24-4893-b904-3e5f8cea58c73
993755APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral SolutionSY59c33fd9-ef24-4893-b904-3e5f8cea58c73
993755codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral SolutionSY59c33fd9-ef24-4893-b904-3e5f8cea58c73
993755codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral SolutionPSNf45ed4dd-6fcf-1de6-e053-2995a90a8c2d2
993755acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral SolutionSCDf45ed4dd-6fcf-1de6-e053-2995a90a8c2d2
993755acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral SolutionSYf45ed4dd-6fcf-1de6-e053-2995a90a8c2d2
993755acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral SolutionSYf45ed4dd-6fcf-1de6-e053-2995a90a8c2d2
993755APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral SolutionSYf45ed4dd-6fcf-1de6-e053-2995a90a8c2d2
993755codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral SolutionSYf45ed4dd-6fcf-1de6-e053-2995a90a8c2d2
993755codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral SolutionPSN9bf3c04c-22d8-493f-8dbd-c10613042ee51
993755acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral SolutionSCD9bf3c04c-22d8-493f-8dbd-c10613042ee51
993755acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral SolutionSY9bf3c04c-22d8-493f-8dbd-c10613042ee51
993755acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral SolutionSY9bf3c04c-22d8-493f-8dbd-c10613042ee51
993755APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral SolutionSY9bf3c04c-22d8-493f-8dbd-c10613042ee51
993755codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral SolutionSY9bf3c04c-22d8-493f-8dbd-c10613042ee51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0121-0504-0400121050404118 mL in 1 BOTTLE118 mlHistorical
0121-0504-05001210504055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0504-1600121050416473 mL in 1 BOTTLE473 mlHistorical
0121-0504-400012105044040 in 1 CASEHistorical