Home NDC 70000-0629 Leader Childrens Multi Symptom Cold
Product NDC 70000-0629
11-digit product format 700000629
Labeler code 70000
Product ID 70000-0629_8e10d570-5e78-4ff3-9a30-bbdba6912b74
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, guaifenesin, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler CARDINAL HEALTH 110, LLC. DBA LEADER
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-15
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
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 2026-12-31
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 Leader Childrens Multi Symptom Cold
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL GUAIFENESIN 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043543 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 70000-0629-1 Leader Childrens Multi Symptom Cold 1 in 1 CARTON LIQUID 1 3 70000-0629-1 Leader Childrens Multi Symptom Cold 118 mL in 1 BOTTLE LIQUID 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0629 LEADER CHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CARDINAL HEALTH 110, LLC. DBA LEADER] 3 Current NDC, 2 package rows 20241219_169ff9cf-fcf5-46a6-b460-259421f2ec07.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 73 of 178 · 3,551 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 70000-0629-1 70000062901 1 BOTTLE in 1 CARTON (70000-0629-1) / 118 mL in 1 BOTTLE 1 bottle 2023-03-15 No No Current