Home NDC 0135-0609 PANADOL
Product NDC 0135-0609
11-digit product format 001350609
Labeler code 0135
Product ID 0135-0609_10c10ae1-2b66-f708-e063-6394a90a0fca
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-03-15
Substance ACETAMINOPHEN
Active strength 500 mg/1
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 Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 200977 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0609-01 PANADOLExtra Strength 24 in 1 BOTTLE TABLET, FILM COATED 24 7 0135-0609-01 PANADOLExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 7 0135-0609-02 PANADOLExtra Strength 50 in 1 BOTTLE TABLET, FILM COATED 50 7 0135-0609-02 PANADOLExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 7 0135-0609-03 PANADOLExtra Strength 100 in 1 BOTTLE TABLET, FILM COATED 100 7 0135-0609-03 PANADOLExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 7 0135-0609-04 PANADOLExtra Strength 50 in 1 CARTON TABLET, FILM COATED 50 7 0135-0609-05 PANADOLExtra Strength 2 in 1 PACKET TABLET, FILM COATED 2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0609 PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 7 Current NDC, Legacy NDC, 8 package rows 20240207_b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b.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 85 · 1,687 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 0135-0609-01 00135060901 1 BOTTLE in 1 CARTON (0135-0609-01) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-03-15 0000-00-00 No No Current 0135-0609-02 00135060902 1 BOTTLE in 1 CARTON (0135-0609-02) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-03-15 0000-00-00 No No Current 0135-0609-03 00135060903 1 BOTTLE in 1 CARTON (0135-0609-03) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-03-15 0000-00-00 No No Current 0135-0609-04 00135060904 50 PACKET in 1 CARTON (0135-0609-04) / 2 TABLET, FILM COATED in 1 PACKET (0135-0609-05) 50 packet 2017-03-15 0000-00-00 No No Current 0135-0609-05 00135060905 2 in 1 PACKET Historical