Home NDC 50580-507 Tylenol Sinus Severe
Product NDC 50580-507
11-digit product format 505800507
Labeler code 50580
Product ID 50580-507_5e691fd8-3462-c044-e063-6294a90ad886
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Kenvue Brands 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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-507-01 Tylenol Sinus Severe 12 in 1 BLISTER PACK TABLET, COATED 12 16 50580-507-01 Tylenol Sinus Severe 2 in 1 CARTON TABLET, COATED 2 16 50580-507-02 Tylenol Sinus Severe 2 in 1 CARTON TABLET, COATED 2 16 50580-507-02 Tylenol Sinus Severe 3 in 1 PACKAGE TABLET, COATED 3 16 50580-507-03 Tylenol Sinus Severe 2 in 1 POUCH TABLET, COATED 2 16 50580-507-04 Tylenol Sinus Severe 50 in 1 CARTON TABLET, COATED 50 16 50580-507-04 Tylenol Sinus Severe 2 in 1 POUCH TABLET, COATED 2 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 hydroxypropyl cellulose (type e) INACTIVE INGREDIENT 66O7AQV0RT TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-507 TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [KENVUE BRANDS LLC] 16 Current NDC, Legacy NDC, 7 package rows 20241103_7a60184f-91a9-4b85-b243-871deca63450.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 50580-507-01 50580050701 2 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2015-05-15 0000-00-00 No No Current 50580-507-02 50580050702 3 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK 3 carton 2020-07-06 No No Current 50580-507-03 50580050703 2 TABLET, COATED in 1 POUCH (50580-507-03) 2017-07-17 0000-00-00 No No Current 50580-507-04 50580050704 50 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH 50 pouch 2017-07-17 0000-00-00 No No Current 50580-507-72 50580050772 3 CARTON in 1 CARTON (50580-507-72) / 1 BLISTER PACK in 1 CARTON / 24 TABLET, COATED in 1 BLISTER PACK 3 carton 2026-03-16 No No Current