Home NDC 70264-025 TYLENOL COLD AND FLU
Product NDC 70264-025
11-digit product format 702640025
Labeler code 70264
Product ID 70264-025_43c8b54c-e070-e4e9-e063-6394a90aab2a
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINPHEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler R J General Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-01
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 AND FLU
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 70264-025-02 TYLENOL COLD AND FLU 50 in 1 BOX TABLET, FILM COATED 50 4 70264-025-02 TYLENOL COLD AND FLU 2 in 1 POUCH TABLET, FILM COATED 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70264-025 TYLENOL COLD AND FLU (ACETAMINPHEN) TABLET, FILM COATED [R J GENERAL CORPORATION] 3 Current NDC, Legacy NDC, 2 package rows 20241030_b618877b-9dbc-4ba2-be2c-bf1922c646cc.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 70264-025-02 70264002502 50 POUCH in 1 BOX (70264-025-02) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2021-05-01 0000-00-00 No No Current