Home NDC 67414-507 Tylenol Sinus Severe
Product NDC 67414-507
11-digit product format 674140507
Labeler code 67414
Product ID 67414-507_09759b68-4bd0-c41f-e063-6294a90a62a4
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler Jones Healthcare Group - Packaging Services, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-25
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 67414-507-00 Tylenol Sinus Severe 2 in 1 POUCH TABLET, COATED 2 6 67414-507-00 Tylenol Sinus Severe 2500 in 1 BOX TABLET, COATED 2500 6 67414-507-04 Tylenol Sinus Severe 50 in 1 CARTON TABLET, COATED 50 6 67414-507-04 Tylenol Sinus Severe 2 in 1 POUCH TABLET, COATED 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67414-507 TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [JONES HEALTHCARE GROUP - PACKAGING SERVICES, INC] 6 Current NDC, Legacy NDC, 4 package rows 20231106_6c90b415-4c5f-49e5-beb6-4cf225797b21.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 73 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 Marketing end Sample Exclude flag Status 67414-507-00 67414050700 2500 POUCH in 1 BOX (67414-507-00) / 2 TABLET, COATED in 1 POUCH 2500 pouch 2018-01-25 0000-00-00 No No Current 67414-507-04 67414050704 50 POUCH in 1 CARTON (67414-507-04) / 2 TABLET, COATED in 1 POUCH 50 pouch 2018-01-25 0000-00-00 No No Current