Home NDC 0135-0620-01 PANADOL
Product NDC 0135-0620
Requested package NDC 0135-0620-01
11-digit product format 001350620
Labeler code 0135
Product ID 0135-0620_10c0dc3d-12b7-e9da-e063-6394a90a5dcf
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen and caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-03-01
Substance ACETAMINOPHEN; CAFFEINE
Active strength 500; 65 mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PANADOL
Brand name suffix Extra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 CAFFEINE 65 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 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307686 Internal RxNorm lookup 1872075 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0620-01 PANADOLExtra 24 in 1 BOTTLE TABLET, FILM COATED 24 4 0135-0620-01 PANADOLExtra 1 in 1 CARTON TABLET, FILM COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0620 PANADOL EXTRA (ACETAMINOPHEN AND CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240207_e5c2d88a-d903-4ca0-b895-f27e791dfc4e.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 1 of 84 · 1,678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0135-0620-01 00135062001 1 BOTTLE in 1 CARTON (0135-0620-01) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-03-01 0000-00-00 No No Current