Home NDC 41520-984 COLD FLU and SORE THROAT RELIEF
Product NDC 41520-984
11-digit product format 415200984
Labeler code 41520
Product ID 41520-984_2778cbf9-89f0-8ec3-e063-6394a90ad0a5
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler FOODHOLD U.S.A., LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-10-05
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 COLD FLU and SORE THROAT RELIEF
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 1656815 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 41520-984-14 COLD FLU and SORE THROAT RELIEF 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 3 41520-984-14 COLD FLU and SORE THROAT RELIEF 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-984 COLD FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FOODHOLD U.S.A., LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241123_1161e5dc-0677-4fb9-964f-971a508098b6.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 41520-984-14 41520098414 2 BLISTER PACK in 1 CARTON (41520-984-14) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2016-10-05 0000-00-00 No No Current