Home NDC 0067-8161 Theraflu Flu Relief Maximum Strength
Product NDC 0067-8161
11-digit product format 000678161
Labeler code 0067
Product ID 0067-8161_132b9415-743c-c981-e063-6394a90ae3de
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr and Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form KIT
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-27
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 Flu Relief Maximum Strength
Brand name suffix Daytime Nighttime Combo Pack
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 247324 Internal RxNorm lookup 1098496 Internal RxNorm lookup 2604579 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 0067-8161-01 Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack 1 in 1 CARTON KIT 1 3 0067-8162-01 Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack 20 in 1 BLISTER PACK TABLET 20 15 mg 3 0067-8163-01 Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack 20 in 1 BLISTER PACK TABLET 20 500 mg 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-8161 THERAFLU FLU RELIEF MAXIMUM STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC] 3 Current NDC, Legacy NDC, 3 package rows 20240310_68d3e88a-d1be-410b-92a1-863903b3aa61.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 Marketing end Sample Exclude flag Status 0067-8161-01 00067816101 1 KIT in 1 CARTON (0067-8161-01) * 20 TABLET in 1 BLISTER PACK (0067-8162-01) * 20 TABLET in 1 BLISTER PACK (0067-8163-01) 1 kit 2022-06-27 0000-00-00 No No Current 0067-8162-01 00067816201 20 in 1 BLISTER PACK Historical 0067-8163-01 00067816301 20 in 1 BLISTER PACK Historical