Home NDC 70264-047 Theraflu Severe Cold Relief Daytime
Product NDC 70264-047
11-digit product format 702640047
Labeler code 70264
Product ID 70264-047_43c91d3a-f1f9-ffcd-e063-6294a90a7860
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HBr
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler R J General Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-12
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 500; 20 mg/1; mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Theraflu Severe Cold Relief Daytime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2670598 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 70264-047-01 Theraflu Severe Cold Relief Daytime 25 in 1 CARTON POWDER, FOR SOLUTION 25 2 70264-047-01 Theraflu Severe Cold Relief Daytime 1 in 1 PACKET POWDER, FOR SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70264-047 THERAFLU SEVERE COLD RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) POWDER, FOR SOLUTION [R J GENERAL CORPORATION] 1 Current NDC, 2 package rows 20241116_8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc.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 Sample Exclude flag Status 70264-047-01 70264004701 25 PACKET in 1 CARTON (70264-047-01) / 1 POWDER, FOR SOLUTION in 1 PACKET 25 packet 2024-11-12 No No Current