FDA.reportPublic FDA data

CVS Childrens Cold and Allergy

Product NDC
69842-639
11-digit product format
698420639
Labeler code
69842
Product ID
69842-639_458251ea-0e80-32bf-e063-6294a90a784a
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
CVS PHARMACY, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-30
Substance
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 5 mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [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
CVS Childrens Cold and Allergy
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 04JA59TNSJ
Rxcui1053258

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
69842-639-04CVS Childrens Cold and Allergy1 in 1 CARTONLIQUID16
69842-639-04CVS Childrens Cold and Allergy118 mL in 1 BOTTLELIQUID1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-639CVS CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]5Current NDC, Legacy NDC, 2 package rows20240821_f4020c08-29f6-4609-834e-191ce6885130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNf4020c08-29f6-4609-834e-191ce68851306
1053258brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDf4020c08-29f6-4609-834e-191ce68851306
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral ElixirSYf4020c08-29f6-4609-834e-191ce68851306
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYf4020c08-29f6-4609-834e-191ce68851306
1053258brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYf4020c08-29f6-4609-834e-191ce68851306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-639-04698420639041 BOTTLE in 1 CARTON (69842-639-04) / 118 mL in 1 BOTTLE1 bottle2020-03-300000-00-00NoNoCurrent