TYLENOL Extra Strength

Product NDC
53209-1001
11-digit product format
532091001
Labeler code
53209
Product ID
53209-1001_37e8d749-91bb-a5bc-e063-6394a90ac8a8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Morning Star OTC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1984-08-19
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
TYLENOL Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440, 209459

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53209-1001-1TYLENOL Extra Strength2 in 1 BLISTER PACKTABLET, FILM COATED21
53209-1001-2TYLENOL Extra Strength25 in 1 POUCHTABLET, FILM COATED251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN8502ea21-937d-4b33-a3e0-ffab5dc38cd81
209459Tylenol Extra Strength 500 MG Oral TabletPSN8502ea21-937d-4b33-a3e0-ffab5dc38cd81
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD8502ea21-937d-4b33-a3e0-ffab5dc38cd81
198440acetaminophen 500 MG Oral TabletSCD8502ea21-937d-4b33-a3e0-ffab5dc38cd81
198440APAP 500 MG Oral TabletSY8502ea21-937d-4b33-a3e0-ffab5dc38cd81
209459APAP 500 MG Oral Tablet [Tylenol]SY8502ea21-937d-4b33-a3e0-ffab5dc38cd81
209459Tylenol 500 MG Oral TabletSY8502ea21-937d-4b33-a3e0-ffab5dc38cd81
209459Tylenol Extra Strength 500 MG Oral TabletSY8502ea21-937d-4b33-a3e0-ffab5dc38cd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53209-1001-1532091001012 in 1 BLISTER PACKHistorical
53209-1001-25320910010225 BLISTER PACK in 1 POUCH (53209-1001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1001-1) 25 blister pack2025-06-19NoNoHistorical