Home NDC 37808-178 DAYTIME SEVERE COLD AND FLU
Product NDC 37808-178
11-digit product format 378080178
Labeler code 37808
Product ID 37808-178_250203e1-6c05-d70c-e063-6394a90a417b
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler HEB
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-05-01
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 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 DAYTIME SEVERE COLD AND FLU
Brand name suffix MAXIMUM STRENGTH
Listing expiration 2026-12-31 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 37808-178-03 DAYTIME SEVERE COLD AND FLUMAXIMUM STRENGTH 12 in 1 BLISTER PACK TABLET, COATED 12 5 37808-178-03 DAYTIME SEVERE COLD AND FLUMAXIMUM STRENGTH 2 in 1 CARTON TABLET, COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-178 DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB] 5 Current NDC, Legacy NDC, 2 package rows 20241023_774e8bee-1ab5-4587-82e4-31da8ec83544.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 37808-178-03 37808017803 2 BLISTER PACK in 1 CARTON (37808-178-03) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2016-05-01 0000-00-00 No No Current