Home NDC 0067-6802 THERAFLU
Product NDC 0067-6802
11-digit product format 000676802
Labeler code 0067
Product ID 0067-6802_107bff13-9a2b-6c45-e063-6294a90a95a2
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-20
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 500; 20; 10 mg/237mL; mg/237mL; mg/237mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 Daytime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/237mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/237mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/237mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1189316 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 0067-6802-02 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 0067-6802-02 THERAFLUSevere Cold Relief Daytime 6 in 1 CARTON POWDER, FOR SOLUTION 6 1 0067-6802-02 THERAFLUSevere Cold Relief Daytime 237 mL in 1 PACKET POWDER, FOR SOLUTION 237 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-6802 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 20240201_e5ef7b85-feee-44a7-bd0e-ed91352c7434.zip 0067-6802 THERAFLU SEVERE COLD RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] 1 Current NDC, 2 package rows 20240204_7d902237-a990-4c5e-875b-291e124e143b.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 6 PACKET in 1 CARTON (0067-6802-02) / 237 mL in 1 PACKET 6 packet 2023-01-20 No No Current