Home NDC 83059-0057 Severe Sinus Congestion and Pain
Product NDC 83059-0057
11-digit product format 830590057
Labeler code 83059
Product ID 83059-0057_4276cd88-1e20-408b-e063-6394a90ae904
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine
Dosage form TABLET, COATED
Route ORAL
Labeler Shield Pharmaceuticals Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-30
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 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 Severe Sinus Congestion and Pain
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 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 362O9ITL9D Internal UNII lookup 495W7451VQ 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 1243679 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 83059-0057-1 Severe Sinus Congestion and Pain 1 in 1 CARTON TABLET, COATED 1 4 83059-0057-1 Severe Sinus Congestion and Pain 12 in 1 BLISTER PACK TABLET, COATED 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83059-0057 SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE) TABLET, COATED [SHIELD PHARMACEUTICALS CORP] 3 Current NDC, 2 package rows 20241228_c296efd0-5030-4a26-a9b0-e66423d995dc.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 98 of 178 · 3,551 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 83059-0057-1 83059005701 1 BLISTER PACK in 1 CARTON (83059-0057-1) / 12 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2024-10-30 No No Current