FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
0121-1008
11-digit product format
001211008
Labeler code
0121
Product ID
0121-1008_7cfdf5a3-ffd5-403b-8421-6275ca7cf02d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA087508
Marketing category
ANDA
Marketing start
1981-08-21
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 30 mg/12.5mL; mg/12.5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Codeine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/12.5mL
CODEINE PHOSPHATE30 mg/12.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993755

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
0121-1008-002023-02-23C16284748780-19d75b9cf-f0b0-f424-e053-dadaa90a57ceAcetaminophen and Codeine Phosphate Oral Solution USP CV
0121-1008-002020-01-31C16284748780-19d75b9cf-f0b0-f424-e053-dadaa90a57ceAcetaminophen and Codeine Phosphate Oral Solution USP CV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1008-12Acetaminophen and Codeine Phosphate12.5 mL in 1 CUP, UNIT-DOSESOLUTION12.531
0121-1008-40Acetaminophen and Codeine Phosphate40 in 1 CASESOLUTION4031
0121-1008-40Acetaminophen and Codeine Phosphate10 in 1 TRAYSOLUTION1031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1008-00ML - Milliliter0121-10088a52f0fd-ac77-4c97-a032-a8302780c5eb12017-09-11
0121-1008-12ML - Milliliter0121-1008314c4bcd-5ff3-44af-9a2c-e9298cf98b2312017-09-11
0121-1008-40ML - Milliliter0121-1008fd47489f-2724-4c70-a897-35925483f57c12024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]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
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1008ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]31Current NDC, 3 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1008-120012110081212.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) 12.5 ml2024-10-07NoNoHistorical
0121-1008-400012110084040 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) 40 tray1981-08-21NoNoHistorical