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 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 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 UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1110988 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 67414-402-00 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
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 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