Home NDC 41250-643 Cold and Flu
Product NDC 41250-643
11-digit product format 412500643
Labeler code 41250
Product ID 41250-643_ba58c7cb-227b-4bf4-a519-8cf4242bec41
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Meijer Distribution Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-08
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
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 Cold and Flu
Brand name suffix Daytime Severe
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
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 1110988 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 41250-643-08 Cold and FluDaytime Severe 2 in 1 CARTON TABLET, FILM COATED 2 10 41250-643-08 Cold and FluDaytime Severe 12 in 1 BLISTER PACK TABLET, FILM COATED 12 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-643 COLD AND FLU DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 9 Current NDC, Legacy NDC, 2 package rows 20250119_5ca7dc60-af0c-47c6-b453-8b39c744eb5b.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 Marketing end Sample Exclude flag Status 41250-643-08 41250064308 2 BLISTER PACK in 1 CARTON (41250-643-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2020-05-08 0000-00-00 No No Current