Home NDC 0067-0115 Theraflu-D Flu Relief Max Strength plus Nasal Decongestant
Product NDC 0067-0115
11-digit product format 000670115
Labeler code 0067
Product ID 0067-0115_178df809-0bd7-7259-e063-6294a90a2b21
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl
Dosage form SYRUP
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-19
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 1000; 30; 60 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes Adrenergic alpha-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-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-D Flu Relief Max Strength plus Nasal Decongestant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 1000 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/30mL
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 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369927 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 0067-0115-01 Theraflu-D Flu Relief Max Strength plus Nasal Decongestant 1 in 1 CARTON SYRUP 1 1 0067-0115-01 Theraflu-D Flu Relief Max Strength plus Nasal Decongestant 237 mL in 1 BOTTLE SYRUP 237 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-0115 THERAFLU-D FLU RELIEF MAX STRENGTH PLUS NASAL DECONGESTANT (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL) SYRUP [HALEON US HOLDINGS LLC] 1 Current NDC, 2 package rows 20240619_e35cb719-9e7d-4b2b-81a4-29e147dd74fa.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 0067-0115-01 00067011501 1 BOTTLE in 1 CARTON (0067-0115-01) / 237 mL in 1 BOTTLE 1 bottle 2024-06-19 No No Current