Home NDC 0067-0111 Theraflu
Product NDC 0067-0111
11-digit product format 000670111
Labeler code 0067
Product ID 0067-0111_91dbb541-6a86-4803-a1fe-1bf61b457c34
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-19
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 10 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
Brand name suffix Severe Cold Relief Soft Chews
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 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 2685209 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 0067-0111-01 TherafluSevere Cold Relief Soft Chews 20 in 1 BOTTLE TABLET, CHEWABLE 20 1 0067-0111-02 TherafluSevere Cold Relief Soft Chews 10 in 1 BOTTLE TABLET, CHEWABLE 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-0111 THERAFLU SEVERE COLD RELIEF SOFT CHEWS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) TABLET, CHEWABLE [HALEON US HOLDINGS LLC] 1 Current NDC, 2 package rows 20240619_91dbb541-6a86-4803-a1fe-1bf61b457c34.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0067-0111-01 00067011101 20 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-01) 2024-06-19 No No Current 0067-0111-02 00067011102 10 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-02) 2024-06-19 No No Current