FDA.reportPublic FDA data

NDC 60432-245-04 - 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
60432-245
Requested NDC
60432-245-04
Package NDCs from labels
60432-245-16, 60432-245-04
Manufacturer
Morton Grove Pharmaceuticals, Inc.
Effective date
2019-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP 120 mg/12 mg per 5 mL CVMorton Grove Pharmaceuticals, Inc.2019-10-28HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-245-04ML - Milliliter60432-245f5903fe2-1f9f-4e86-8179-b4f409b3640612012-07-24
60432-245-16ML - Milliliter60432-2459c7056f5-c901-4a44-896c-3bb4fee9c8eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
AcetaminophenACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
AlcoholINACTIVE INGREDIENT3K9958V90MACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
CaramelINACTIVE INGREDIENTT9D99G2B1RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
FD&C RED No. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
SucroseINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]4

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 8 of 325 · 6,499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
unii: 362O9ITL9D
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
unii: 362O9ITL9D
SpectrumETHYL ALCOHOLMedline Industries, LP428b1cb9-7db8-3141-e054-00144ff8d46c2026-08-25WarningsExact identifier
unii: 3K9958V90M
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
unii: 362O9ITL9D
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Feverall ChildrensACETAMINOPHENSun Pharmaceutical Industries, Inc.861e2987-5473-45b0-b2a6-f980a9b0e8092026-08-24WarningsExact identifier
unii: 362O9ITL9D
Ethyl alcohol 62%ETHYL ALCOHOL 62%UpLift Brands, LLC59cea08d-299a-2f50-e063-6394a90a6e142026-08-24Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
unii: 362O9ITL9D
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
unii: 3K9958V90M
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
unii: 362O9ITL9D
SOUR LEMON Hand Sanitizer STRAWBERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9b0101ef-54cf-466e-8c27-4429d5cf4d172026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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