FDA.reportPublic FDA data

CareOne Childrens Cold and Cough

Product NDC
41520-987
11-digit product format
415200987
Labeler code
41520
Product ID
41520-987_842bef1a-4b77-4e06-a119-785a8e17e19b
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
American Sales Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-09-07
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
CareOne 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
41520-987-26CareOne Childrens Cold and Cough1 in 1 CARTONSOLUTION14
41520-987-26CareOne Childrens Cold and Cough118 mL in 1 BOTTLESOLUTION1184

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03CAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-987CAREONE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [AMERICAN SALES COMPANY]4Current NDC, Legacy NDC, 2 package rows20241119_cce5ba29-d529-4fe1-8ab9-fc5bcd5d4d14.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 SolutionPSNcce5ba29-d529-4fe1-8ab9-fc5bcd5d4d144
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDcce5ba29-d529-4fe1-8ab9-fc5bcd5d4d144
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSYcce5ba29-d529-4fe1-8ab9-fc5bcd5d4d144
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYcce5ba29-d529-4fe1-8ab9-fc5bcd5d4d144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-987-26415200987261 BOTTLE in 1 CARTON (41520-987-26) / 118 mL in 1 BOTTLE1 bottle2017-10-090000-00-00NoNoCurrent