Home NDC 0135-7033 Panadol
Product NDC 0135-7033
11-digit product format 001357033
Labeler code 0135
Product ID 0135-7033_509dd8bd-dcd2-09e6-e063-6394a90a2d09
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr
Dosage form TABLET
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 500; 15 mg/1; mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 Panadol
Brand name suffix Cold and Flu Day
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
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 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 247324 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 0135-7033-20 PanadolCold and Flu Day 2 in 1 CARTON TABLET 2 2 0135-7033-20 PanadolCold and Flu Day 10 in 1 BLISTER PACK TABLET 10 2 0135-7033-50 PanadolCold and Flu Day 2 in 1 POUCH TABLET 2 2 0135-7033-50 PanadolCold and Flu Day 50 in 1 CARTON TABLET 50 2
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 0135-7033-20 00135703320 2 BLISTER PACK in 1 CARTON (0135-7033-20) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2026-04-30 No No Current 0135-7033-50 00135703350 50 POUCH in 1 CARTON (0135-7033-50) / 2 TABLET in 1 POUCH 50 pouch 2026-04-30 No No Current