FDA.reportPublic FDA data

up and up 12 hour cough relief

Product NDC
11673-114
11-digit product format
116730114
Labeler code
11673
Product ID
11673-114_3a35c733-41f0-480d-9a3b-00f292582c5c
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Target Corporation
Application
ANDA091135
Marketing category
ANDA
Marketing start
2012-10-23
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
up and up 12 hour cough relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-114-21up and up 12 hour cough relief89 mL in 1 BOTTLESUSPENSION896
11673-114-21up and up 12 hour cough relief1 in 1 CARTONSUSPENSION16
11673-114-28up and up 12 hour cough relief1 in 1 CARTONSUSPENSION16
11673-114-28up and up 12 hour cough relief148 mL in 1 BOTTLESUSPENSION1486

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27UP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554UP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
TRIACETININACTIVE INGREDIENTXHX3C3X673UP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEUP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-114UP AND UP 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TARGET CORPORATION]5Current NDC, Legacy NDC, 4 package rows20250523_a8acec73-dc66-444e-9438-370893cd5129.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNa8acec73-dc66-444e-9438-370893cd51296
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDa8acec73-dc66-444e-9438-370893cd51296
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYa8acec73-dc66-444e-9438-370893cd51296
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYa8acec73-dc66-444e-9438-370893cd51296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-114-211167301142189 mL in 1 BOTTLE89 mlHistorical
11673-114-28116730114281 BOTTLE in 1 CARTON (11673-114-28) / 148 mL in 1 BOTTLE1 bottle2014-03-030000-00-00NoNoCurrent