FDA.reportPublic FDA data

Childrens Multi-Symptom Cold Plus

Product NDC
63868-374
11-digit product format
638680374
Labeler code
63868
Product ID
63868-374_ab5fc86e-c83a-4392-a45c-3ccc9bd52e10
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
Dosage form
SUSPENSION
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-31
Marketing end
2020-12-31
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
160 mg/5mL; mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-374DDiscontinued by firm2026-07-31
excluded packagepackage63868-37463868-374-04DDiscontinued by firm2026-07-31

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS MULTI-SYMPTOM COLD PLUS DYE-FREE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1