Home NDC 85766-162 Medique Cold Cough Product
Product NDC 85766-162
11-digit product format 857660162
Labeler code 85766
Product ID 85766-162_4a5ea172-8d70-4e54-e063-6394a90a4fd1
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ,
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sportpharm LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-26
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10; 325; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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 Medique Cold Cough Product
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094538 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85766-162-36 Medique Cold Cough Product 75 in 1 BOX TABLET, FILM COATED 75 1 85766-162-36 Medique Cold Cough Product 2 in 1 PACKET TABLET, FILM COATED 2 1 85766-162-80 Medique Cold Cough Product 40 in 1 BOX TABLET, FILM COATED 40 1 85766-162-80 Medique Cold Cough Product 2 in 1 PACKET TABLET, FILM COATED 2 1
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 · 3,550 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-162-36 85766016236 75 PACKET in 1 BOX (85766-162-36) / 2 TABLET, FILM COATED in 1 PACKET 75 packet 2026-02-09 No No Current 85766-162-80 85766016280 40 PACKET in 1 BOX (85766-162-80) / 2 TABLET, FILM COATED in 1 PACKET 40 packet 2026-02-09 No No Current