Home NDC 55319-754 Childrens Cough and Cold
Product NDC 55319-754
11-digit product format 553190754
Labeler code 55319
Product ID 55319-754_f29a5303-a3d0-4f99-ac66-624ac5787d4d
Type HUMAN OTC DRUG
Nonproprietary name chlorpheniramine maleate, dextrometrorphan HBr
Dosage form LIQUID
Route ORAL
Labeler FAMILY DOLLAR SERVICES INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-08
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 2; 15 mg/10mL; mg/10mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Cough and Cold
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 15 mg/10mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-754-04 Childrens Cough and Cold 118 mL in 1 BOTTLE LIQUID 118 4 55319-754-04 Childrens Cough and Cold 1 in 1 CARTON LIQUID 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-754 CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [FAMILY DOLLAR SERVICES INC] 3 Current NDC, 2 package rows 20240905_4c06b5cf-036d-4bbd-b055-a07bf2015beb.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-754-04 55319075404 1 BOTTLE in 1 CARTON (55319-754-04) / 118 mL in 1 BOTTLE 1 bottle 2023-05-08 No No Current