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 6 of 325 · 6,499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f875e065-7b3e-45dc-8a33-b893ab8306952026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30e11bf0-1a21-45b1-adf9-cf3845419a982026-08-31WarningsExact identifier
unii: 3K9958V90M
Swisher Instant Hand Sanitizer GelALCOHOLEcolab Inc.1f84e842-ece4-4eb7-9ccf-d86cec78dbf22026-08-31WarningsExact identifier
unii: 3K9958V90M
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
unii: 3K9958V90M
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
unii: 3K9958V90M
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
unii: 362O9ITL9D
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
unii: 3K9958V90M
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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