Home NDC 0067-8204 Theraflu Flu Relief Max Strength
Product NDC 0067-8204
11-digit product format 000678204
Labeler code 0067
Product ID 0067-8204_230cebe9-cd25-45a4-a561-0d7c147f9efe
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr
Dosage form SYRUP
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-27
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 1000; 30 mg/30mL; mg/30mL
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 2027-12-31
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 Flu Relief Max Strength
Brand name suffix Daytime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 1000 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL
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 1359455 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 0067-8204-01 Theraflu Flu Relief Max StrengthDaytime 245.5 mL in 1 BOTTLE SYRUP 245.5 5 0067-8204-01 Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack 245.5 mL in 1 BOTTLE SYRUP 245.5 mL 30 mg in 30mL 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-8204 THERAFLU FLU RELIEF MAX STRENGTH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) SYRUP [HALEON US HOLDINGS LLC] 4 Current NDC, 1 package rows 20241219_0324195f-506d-4747-990e-ad44e2a117d9.zip 0067-8204 THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC] 3 Current NDC 20240310_3618ccf0-1f30-42e0-bb50-bfa45cf2b583.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 73 of 178 · 3,551 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 0067-8204-01 00067820401 245.5 mL in 1 BOTTLE (0067-8204-01) 245.5 ml 2022-06-27 No No Current