FDA.reportPublic FDA data

Acetaminophen

Product NDC
72789-267
11-digit product format
727890267
Labeler code
72789
Product ID
72789-267_2e5d566b-3e9d-35bd-e063-6294a90a0513
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-11
Substance
ACETAMINOPHEN
Active strength
325 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
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui313782

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-267-20Acetaminophen20 in 1 BOTTLE, PLASTICTABLET207
72789-267-30Acetaminophen30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-267ACETAMINOPHEN TABLET [PD-RX PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20250221_da7d95af-6583-429d-8d04-e0424f32e9ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNda7d95af-6583-429d-8d04-e0424f32e9ad7
313782acetaminophen 325 MG Oral TabletSCDda7d95af-6583-429d-8d04-e0424f32e9ad7
313782APAP 325 MG Oral TabletSYda7d95af-6583-429d-8d04-e0424f32e9ad7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-267-207278902672020 TABLET in 1 BOTTLE, PLASTIC (72789-267-20) 20 tablet2022-08-010000-00-00NoNoCurrent
72789-267-307278902673030 TABLET in 1 BOTTLE, PLASTIC (72789-267-30) 30 tablet2023-04-05NoNoCurrent