Home NDC 0067-0122 Theraflu
Product NDC 0067-0122
11-digit product format 000670122
Labeler code 0067
Product ID 0067-0122_f147d82e-4429-4c7b-bd2b-e21a09f21c92
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hbr, diphenhydramine hcl
Dosage form KIT
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-15
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 Combo Pack
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2670598 Internal RxNorm lookup 2670677 Internal RxNorm lookup 2679420 Internal RxNorm lookup 2679425 Internal RxNorm lookup 2679426 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 0067-0100-06 TherafluSevere Cold Relief Combo Pack 1 in 1 PACKET POWDER, FOR SOLUTION 1 500 mg 1 0067-0100-06 TherafluSevere Cold Relief Combo Pack 6 in 1 CARTON POWDER, FOR SOLUTION 20 mg 1 0067-0101-06 TherafluSevere Cold Relief Combo Pack 1 in 1 PACKET POWDER, FOR SOLUTION 1 25 mg 1 0067-0101-06 TherafluSevere Cold Relief Combo Pack 6 in 1 CARTON POWDER, FOR SOLUTION 650 mg 1 0067-0122-01 TherafluSevere Cold Relief Combo Pack 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 0067-0122 THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] 1 Current NDC, 5 package rows 20240415_f147d82e-4429-4c7b-bd2b-e21a09f21c92.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 0067-0100-06 00067010006 1 in 1 PACKET Historical 0067-0101-06 00067010106 1 in 1 PACKET Historical 0067-0122-01 00067012201 1 KIT in 1 PACKAGE, COMBINATION (0067-0122-01) * 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0067-0101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET 1 kit 2024-04-15 No No Current