FDA.reportPublic FDA data

Acetaminophen

Product NDC
68788-8636
11-digit product format
687888636
Labeler code
68788
Product ID
68788-8636_6e797473-afdf-45cc-b1d7-aaa1ce5f79e6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Preferrred Pharmaceuticals Inc.
Application
343
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-17
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8636-1Acetaminophen100 in 1 BOTTLETABLET1003
68788-8636-2Acetaminophen20 in 1 BOTTLETABLET203
68788-8636-3Acetaminophen30 in 1 BOTTLETABLET303
68788-8636-5Acetaminophen50 in 1 BOTTLETABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8636-1EA - Each68788-86365ebead29-c0d3-40f6-920d-6e328c8dcd1012024-07-12
68788-8636-2EA - Each68788-8636890fbd52-a6ef-478c-8bc0-c5807b04736c12024-07-12
68788-8636-3EA - Each68788-86360d892719-638f-4ec0-b3e5-d6a7c9520ce712024-07-12
68788-8636-5EA - Each68788-8636f2f0f44b-5f06-49d0-bebd-3d508411491b12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8636ACETAMINOPHEN TABLET [PREFERRRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20250509_cb92ebea-86be-4bdf-a608-50be8be770fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNcb92ebea-86be-4bdf-a608-50be8be770fb3
198440acetaminophen 500 MG Oral TabletSCDcb92ebea-86be-4bdf-a608-50be8be770fb3
198440APAP 500 MG Oral TabletSYcb92ebea-86be-4bdf-a608-50be8be770fb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8636-168788863601100 TABLET in 1 BOTTLE (68788-8636-1) 100 tablet2024-04-17NoNoHistorical
68788-8636-26878886360220 TABLET in 1 BOTTLE (68788-8636-2) 20 tablet2024-04-17NoNoHistorical
68788-8636-36878886360330 TABLET in 1 BOTTLE (68788-8636-3) 30 tablet2024-04-17NoNoHistorical
68788-8636-56878886360550 TABLET in 1 BOTTLE (68788-8636-5) 50 tablet2024-04-17NoNoHistorical