Home NDC 0067-0105 Theraflu
Product NDC 0067-0105
11-digit product format 000670105
Labeler code 0067
Product ID 0067-0105_438014e3-6d78-1332-e063-6394a90afc47
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form SYRUP
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 650; 25 mg/30mL; mg/30mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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/30mL DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1294607 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 0067-0105-08 TherafluSevere Cold Relief Nighttime 245.5 mL in 1 BOTTLE SYRUP 245.5 4 0067-0105-08 TherafluSevere Cold Relief 245.5 mL in 1 BOTTLE SYRUP 1 mL 650 mg in 30mL 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-0105 THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) SYRUP [HALEON US HOLDINGS LLC] 3 Current NDC, 1 package rows 20250116_c24b9489-208c-472b-8ae5-c6e86c12e04d.zip 0067-0105 THERAFLU SEVERE COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN) KIT [HALEON US HOLDINGS LLC] 1 Current NDC 20241016_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf.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 0067-0105-08 00067010508 245.5 mL in 1 BOTTLE (0067-0105-08) 245.5 ml 2023-12-01 No No Current