Home NDC 0067-0107 Theraflu
Product NDC 0067-0107
11-digit product format 000670107
Labeler code 0067
Product ID 0067-0107_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Diphenphydramine HCl, Guaifenesin
Dosage form KIT
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
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
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1042695 Internal RxNorm lookup 1294607 Internal RxNorm lookup 2695452 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 0067-0104-08 TherafluSevere Cold Relief 245.5 mL in 1 BOTTLE SYRUP 1 mL 650 mg in 30mL 1 0067-0105-08 TherafluSevere Cold Relief 245.5 mL in 1 BOTTLE SYRUP 1 mL 650 mg in 30mL 1 0067-0107-01 TherafluSevere Cold Relief 1 in 1 PACKAGE, COMBINATION KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-0107 THERAFLU SEVERE COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN) KIT [HALEON US HOLDINGS LLC] 1 Current NDC, 3 package rows 20241016_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf.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 0067-0104-08 00067010408 245.5 mL in 1 BOTTLE 245.5 ml Historical 0067-0105-08 00067010508 245.5 mL in 1 BOTTLE 245.5 ml Historical 0067-0107-01 00067010701 1 KIT in 1 PACKAGE, COMBINATION (0067-0107-01) * 245.5 mL in 1 BOTTLE (0067-0104-08) * 245.5 mL in 1 BOTTLE (0067-0105-08) 1 kit 2024-02-01 No No Current