FDA.reportPublic FDA data

TARGET CHILDRENs COLD and COUGH

Product NDC
82442-645
11-digit product format
824420645
Labeler code
82442
Product ID
82442-645_42d79940-ae92-eec7-e063-6294a90a9aae
Type
HUMAN OTC DRUG
Nonproprietary name
brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
TARGET CORPORATION
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-17
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 10; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TARGET CHILDRENs COLD and COUGH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1090463

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82442-645-04TARGET CHILDRENs COLD and COUGH118 mL in 1 BOTTLELIQUID1185
82442-645-04TARGET CHILDRENs COLD and COUGH1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82442-645TARGET CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TARGET CORPORATION]4Current NDC, 2 package rows20241120_eb912834-1b14-484d-90f7-a8deb52c0d4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090463brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNeb912834-1b14-484d-90f7-a8deb52c0d4e5
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDeb912834-1b14-484d-90f7-a8deb52c0d4e5
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSYeb912834-1b14-484d-90f7-a8deb52c0d4e5
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYeb912834-1b14-484d-90f7-a8deb52c0d4e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82442-645-04824420645041 BOTTLE in 1 CARTON (82442-645-04) / 118 mL in 1 BOTTLE1 bottle2024-06-17NoNoHistorical