Home NDC 85237-1955 Tylenol Sinus Severe
Product NDC 85237-1955
11-digit product format 852371955
Labeler code 85237
Product ID 85237-1955_52c5c1df-46bc-f82a-e063-6294a90af6f0
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Select Consumer Group LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-05-15
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 Tylenol Sinus 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
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.
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 99 of 180 · 3,583 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85237-1955-1 85237195501 1 POUCH in 1 BLISTER PACK (85237-1955-1) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 1 pouch 2025-06-04 No No Current 85237-1955-2 85237195502 2 POUCH in 1 BLISTER PACK (85237-1955-2) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 2 pouch 2025-06-04 No No Current 85237-1955-3 85237195503 20 POUCH in 1 CARTON (85237-1955-3) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 20 pouch 2025-06-04 No No Current 85237-1955-4 85237195504 25 POUCH in 1 CARTON (85237-1955-4) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 25 pouch 2025-06-04 No No Current 85237-1955-6 85237195506 50 POUCH in 1 CARTON (85237-1955-6) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 50 pouch 2025-06-04 No No Current 85237-1955-7 85237195507 3 POUCH in 1 BLISTER PACK (85237-1955-7) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 3 pouch 2025-06-04 No No Current