Home NDC 49035-478 Severe Congestion and Sinus Relief
Product NDC 49035-478
11-digit product format 490350478
Labeler code 49035
Product ID 49035-478_c7b5c2f1-fffe-4b05-9dd8-0b5f4417d6a5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-04-30
Marketing end 2026-12-28
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 400; 10 mg/20mL; mg/20mL; mg/20mL
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
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 Severe Congestion and Sinus Relief
Brand name suffix Maximum Strength Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/20mL GUAIFENESIN 400 mg/20mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49035-478-06 Severe Congestion and Sinus ReliefMaximum Strength 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-478 SEVERE CONGESTION AND SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)] 4 Current NDC, Legacy NDC, 1 package rows 20240323_aaccafe6-2e76-4023-a5d8-bcec27f60f08.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 49035-478-06 49035047806 177 mL in 1 BOTTLE, PLASTIC (49035-478-06) 177 ml 2018-04-30 2026-12-28 No No Current