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 7 of 325 · 6,499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLBreckenridge Pharmaceutical Incbe10b253-d72a-4f57-aa27-94c70ae8aed32026-08-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.40d4a71e-341e-48b3-b925-ba35b7910dff2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GSL05Y1MN6
unii: 362O9ITL9D
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLI WORLD, LLC2e274b4a-953e-47ce-aa73-81576a4677102026-08-27WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Cherry PieALCOHOLI WORLD, LLC771fdce8-c633-4592-9bbf-5985c2536f2d2026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care LAVENDER VANILLA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.549c6774-a785-4a12-9ff9-9ba17befcc392026-08-27WarningsExact identifier
unii: 3K9958V90M
major acetaminophenACETAMINOPHENMajor Pharmaceuticalsca9e1dae-eefb-4653-952f-2fde090596932026-08-27WarningsExact identifier
unii: 362O9ITL9D
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
unii: 3K9958V90M
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
unii: 362O9ITL9D
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: 362O9ITL9D
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
unii: 3K9958V90M
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
unii: 362O9ITL9D
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: 362O9ITL9D
DG Health 8 Hour Pain ReliefACETAMINOPHENDolgencorp Incd102e8a2-2fff-48cb-9864-7582fde956ed2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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