Home NDC 49580-0415 Severe Cold and Flu Relief
Product NDC 49580-0415
11-digit product format 495800415
Labeler code 49580
Product ID 49580-0415_c005f7ca-3f3b-4dbb-80fe-8cde626f13d5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-26
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 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 Severe Cold and Flu Relief
Brand name suffix Daytime
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0415-8 Severe Cold and Flu ReliefDaytime 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0415 SEVERE COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240426_5872fed8-862b-44a2-a06e-51ebf8618271.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 49580-0415-8 49580041508 237 mL in 1 BOTTLE, PLASTIC (49580-0415-8) 237 ml 2021-03-26 0000-00-00 No No Current