Home NDC 67751-239 Tylenol Sinus Severe
Product NDC 67751-239
11-digit product format 677510239
Labeler code 67751
Product ID 67751-239_435b5b96-73d0-4d01-e063-6394a90ae4dd
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Navajo Manufacturing Company Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-19
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 Tylenol Sinus Severe
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 67751-239-01 Tylenol Sinus Severe 1 in 1 CARTON TABLET, COATED 1 1 67751-239-01 Tylenol Sinus Severe 2 in 1 POUCH TABLET, COATED 2 1 67751-239-02 Tylenol Sinus Severe 2 in 1 POUCH TABLET, COATED 2 1 67751-239-02 Tylenol Sinus Severe 2 in 1 CARTON TABLET, COATED 2 1
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 67751-239-01 67751023901 1 POUCH in 1 CARTON (67751-239-01) / 2 TABLET, COATED in 1 POUCH 1 pouch 2025-02-19 No No Current 67751-239-02 67751023902 2 POUCH in 1 CARTON (67751-239-02) / 2 TABLET, COATED in 1 POUCH 2 pouch 2025-02-19 No No Current