Home NDC 79481-3572 Cold and Head Congestion Severe
Product NDC 79481-3572
11-digit product format 794813572
Labeler code 79481
Product ID 79481-3572_fb078d01-5725-4bf7-85ae-b08d61ed4de5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Meijer Distribution, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-10
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Cold and Head Congestion Severe
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79481-3572-8 Cold and Head Congestion Severe 2 in 1 CARTON TABLET, FILM COATED 2 3 79481-3572-8 Cold and Head Congestion Severe 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79481-3572 COLD AND HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION, INC.] 2 Current NDC, 2 package rows 20240911_a41c62aa-90a4-4958-984f-b2fed0276c8a.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 Sample Exclude flag Status 79481-3572-8 79481357208 2 BLISTER PACK in 1 CARTON (79481-3572-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2024-09-10 No No Current