Home NDC 50269-402 Tylenol Cold Plus Flu Severe
Product NDC 50269-402
11-digit product format 502690402
Labeler code 50269
Product ID 50269-402_2a957ca2-7bd7-c0de-e063-6294a90a2aba
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler JC World Bell Wholesale Co., Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-09-20
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Tylenol Cold Plus Flu Severe
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ Rxcui 1110988
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50269-402-25 Tylenol Cold Plus Flu Severe 25 in 1 BOX TABLET, FILM COATED 25 6 50269-402-25 Tylenol Cold Plus Flu Severe 2 in 1 POUCH TABLET, FILM COATED 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50269-402 TYLENOL COLD PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JC WORLD BELL WHOLESALE CO., INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250101_a986c666-3fb3-42cf-b0fb-d95002b89a23.zip
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 50269-402-25 50269040225 25 POUCH in 1 BOX (50269-402-25) / 2 TABLET, FILM COATED in 1 POUCH 25 pouch 2018-09-20 0000-00-00 No No Current