Home NDC 76281-519 CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY
Product NDC 76281-519
11-digit product format 762810519
Labeler code 76281
Product ID 76281-519_2f25ce5a-4e46-4e77-be6d-041a502a5049
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL
Dosage form LIQUID
Route ORAL
Labeler AptaPharma Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 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 COLD COUGH and SORE THROAT MIXED BERRY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL GUAIFENESIN 200 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1593450 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76281-519-24 CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY 1 in 1 CARTON LIQUID 1 2 76281-519-24 CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY 118 mL in 1 BOTTLE LIQUID 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76281-519 CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.] 2 Current NDC, 2 package rows 20240202_5962a73e-72e4-493b-94a7-43bc6cf9c82f.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 76281-519-24 76281051924 1 BOTTLE in 1 CARTON (76281-519-24) / 118 mL in 1 BOTTLE 1 bottle 2024-01-30 No No Current