Home NDC 70000-0192 Leader Daytime Severe Cold and Flu
Product NDC 70000-0192
11-digit product format 700000192
Labeler code 70000
Product ID 70000-0192_89165902-d4db-43a8-a6d4-588417001930
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 110, LLC. dba Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-23
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
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 Daytime Severe Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/15mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL GUAIFENESIN 200 mg/15mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
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 1369842 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 70000-0192-1 Leader Daytime Severe Cold and Flu 237 mL in 1 BOTTLE SOLUTION 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0192 LEADER DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] 4 Current NDC, Legacy NDC, 1 package rows 20241030_d38537c6-9553-4e93-a83e-11ed48c955ab.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 Marketing end Sample Exclude flag Status 70000-0192-1 70000019201 237 mL in 1 BOTTLE (70000-0192-1) 237 ml 2016-11-23 0000-00-00 No No Current