Home NDC 0067-6804 Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime
Product NDC 0067-6804
11-digit product format 000676804
Labeler code 0067
Product ID 0067-6804_103fee61-db67-5ad2-e063-6394a90a572a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl
Dosage form KIT
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-20
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 Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime
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 1189316 Internal RxNorm lookup 1659960 Internal RxNorm lookup 2640034 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-6802-02 Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime 237 mL in 1 PACKET POWDER, FOR SOLUTION 1422 mL 10 mg in 237mL 2 0067-6802-02 Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime 6 in 1 CARTON POWDER, FOR SOLUTION 20 mg in 237mL 2 0067-6803-02 Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime 6 in 1 CARTON POWDER, FOR SOLUTION 25 mg in 237mL 2 0067-6803-02 Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime 237 mL in 1 PACKET POWDER, FOR SOLUTION 1422 mL 25 mg in 237mL 2 0067-6804-02 Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime 1 in 1 PACKAGE, COMBINATION KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-6804 THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] 2 Current NDC, 5 package rows 20240201_e5ef7b85-feee-44a7-bd0e-ed91352c7434.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 0067-6802-02 00067680202 237 mL in 1 PACKET 237 ml Historical 0067-6803-02 00067680302 6 in 1 CARTON Historical 0067-6804-02 00067680402 1 KIT in 1 PACKAGE, COMBINATION (0067-6804-02) * 6 PACKET in 1 CARTON (0067-6802-02) / 237 mL in 1 PACKET * 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET 1 kit 2023-01-20 No No Current