FDA.reportPublic FDA data

PANADOL

Product NDC
0135-7011
11-digit product format
001357011
Labeler code
0135
Product ID
0135-7011_10c12d49-cd3c-e104-e063-6294a90a4e5a
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
2021-02-15
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
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440, 200977

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-7011-01PANADOLExtra Strength2 in 1 POUCHTABLET, FILM COATED28
0135-7011-02PANADOLExtra Strength24 in 1 BOTTLETABLET, FILM COATED248
0135-7011-02PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED18
0135-7011-03PANADOLExtra Strength50 in 1 BOTTLETABLET, FILM COATED508
0135-7011-03PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED18
0135-7011-04PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED18
0135-7011-04PANADOLExtra Strength100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-7011PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 7 package rows20240207_9d384e88-5c11-4600-ac6c-a38371570138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN9d384e88-5c11-4600-ac6c-a383715701388
200977Panadol Extra Strength 500 MG Oral TabletPSN9d384e88-5c11-4600-ac6c-a383715701388
200977acetaminophen 500 MG Oral Tablet [Panadol]SBD9d384e88-5c11-4600-ac6c-a383715701388
198440acetaminophen 500 MG Oral TabletSCD9d384e88-5c11-4600-ac6c-a383715701388
198440APAP 500 MG Oral TabletSY9d384e88-5c11-4600-ac6c-a383715701388
200977APAP 500 MG Oral Tablet [Panadol]SY9d384e88-5c11-4600-ac6c-a383715701388
200977Panadol 500 MG Oral TabletSY9d384e88-5c11-4600-ac6c-a383715701388
200977Panadol Extra Strength 500 MG Oral TabletSY9d384e88-5c11-4600-ac6c-a383715701388

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-7011-01001357011012 TABLET, FILM COATED in 1 POUCH (0135-7011-01) 2021-06-110000-00-00NoNoCurrent
0135-7011-02001357011021 BOTTLE in 1 CARTON (0135-7011-02) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-06-080000-00-00NoNoCurrent
0135-7011-03001357011031 BOTTLE in 1 CARTON (0135-7011-03) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-02-150000-00-00NoNoCurrent
0135-7011-04001357011041 BOTTLE in 1 CARTON (0135-7011-04) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-03-190000-00-00NoNoCurrent