Home NDC 67414-402 Tylenol Cold Plus Flu Severe
Product NDC 67414-402
11-digit product format 674140402
Labeler code 67414
Product ID 67414-402_0975bb48-2459-e8bd-e063-6394a90ae8d9
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Jones Healthcare Group - Packaging Services, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-25
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
Brand name suffix 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 67414-402-00 Tylenol Cold Plus Flu Severe Severe 2500 in 1 BOX TABLET, FILM COATED 2500 6 67414-402-00 Tylenol Cold Plus Flu Severe Severe 2 in 1 POUCH TABLET, FILM COATED 2 6 67414-402-02 Tylenol Cold Plus Flu Severe Severe 2 in 1 POUCH TABLET, FILM COATED 2 6 67414-402-02 Tylenol Cold Plus Flu Severe Severe 50 in 1 CARTON TABLET, FILM COATED 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67414-402 TYLENOL COLD PLUS FLU SEVERE SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JONES HEALTHCARE GROUP - PACKAGING SERVICES, INC] 6 Current NDC, Legacy NDC, 4 package rows 20231106_8b8582c0-8aef-482f-9738-2f1d4e325d64.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 67414-402-00 67414040200 2500 POUCH in 1 BOX (67414-402-00) / 2 TABLET, FILM COATED in 1 POUCH 2500 pouch 2018-01-25 0000-00-00 No No Current 67414-402-02 67414040202 50 POUCH in 1 CARTON (67414-402-02) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2018-01-25 0000-00-00 No No Current