Home NDC 0067-6803 Theraflu
Product NDC 0067-6803
11-digit product format 000676803
Labeler code 0067
Product ID 0067-6803_10682cca-1329-1e41-e063-6394a90a7e21
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DIPHENHYDRAMINE HCl, 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; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 25; 10 mg/237mL; mg/237mL; mg/237mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Nighttime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/237mL DIPHENHYDRAMINE HYDROCHLORIDE 25 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 TC2D6JAD40 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 1659960 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 0067-6803-02 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 0067-6803-02 TherafluSevere Cold Relief Nighttime 237 mL in 1 PACKET POWDER, FOR SOLUTION 237 1 0067-6803-02 TherafluSevere Cold Relief Nighttime 6 in 1 CARTON POWDER, FOR SOLUTION 6 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-6803 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 0067-6803 THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] 1 Current NDC, 2 package rows 20240203_4daca846-8511-4303-9e6c-9469f7f260ba.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 0067-6803-02 00067680302 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET 6 packet 2023-01-20 No No Current