Home NDC 47682-435 Medique Decorel Forte
Product NDC 47682-435
11-digit product format 476820435
Labeler code 47682
Product ID 47682-435_3e4fe7f8-b07f-5ac2-e063-6394a90afc08
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unifirst First Aid Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-26
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 5; 325; 10; 100 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 Medique Decorel Forte
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 100 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 1098435 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 47682-435-36 Medique Decorel Forte 75 in 1 BOX TABLET, FILM COATED 75 5 47682-435-80 Medique Decorel Forte 40 in 1 BOX TABLET, FILM COATED 40 5 47682-435-99 Medique Decorel Forte 2 in 1 PACKET TABLET, FILM COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47682-435 MEDIQUE DECOREL FORTE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST PLUS COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] 4 Current NDC, Legacy NDC, 3 package rows 20240915_e64c283b-0efa-0bfd-e053-2a95a90ab71d.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 123 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 47682-435-36 47682043536 75 PACKET in 1 BOX (47682-435-36) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) 75 packet 2022-12-12 0000-00-00 No No Current 47682-435-80 47682043580 40 PACKET in 1 BOX (47682-435-80) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) 40 packet 2022-09-26 0000-00-00 No No Current 47682-435-99 47682043599 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) 2022-09-26 No No Current