FDA.reportPublic FDA data

Acetaminophen

Product NDC
68788-8636
Requested package NDC
68788-8636-2
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb92ebea-86be-4bdf-a608-50be8be770fbAvailable on FDA.report

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

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENPreferrred Pharmaceuticals Inc.cb92ebea-86be-4bdf-a608-50be8be770fb2026-04-15WarningsExact identifier
ndc (package): 68788-8636-2
ndc (product): 68788-8636
ndc11 (package): 68788863602

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
68788-8636-26878886360220 TABLET in 1 BOTTLE (68788-8636-2) 20 tablet2024-04-17NoNoCurrent