FDA.reportPublic FDA data

Acetaminophen

Product NDC
69822-692
11-digit product format
698220692
Labeler code
69822
Product ID
69822-692_eec7bac5-57d6-633f-e053-2a95a90a51e6
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Southern Sales & Service, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69822-692DDiscontinued by firm2026-10-05
excluded packagepackage69822-69269822-692-10DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-692-10Acetaminophen325 in 1 BOTTLETABLET3255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-692ACETAMINOPHEN TABLET [SOUTHERN SALES & SERVICE, INC.]5Legacy NDC, 1 package rows20231201_8b838af4-a74d-47b4-952e-dcf5598b08e1.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
AcetaminophenACETAMINOPHENSouthern Sales & Service, Inc.8b838af4-a74d-47b4-952e-dcf5598b08e12023-11-29WarningsExact identifier
ndc (product): 69822-692

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN8b838af4-a74d-47b4-952e-dcf5598b08e15
313782acetaminophen 325 MG Oral TabletSCD8b838af4-a74d-47b4-952e-dcf5598b08e15
313782APAP 325 MG Oral TabletSY8b838af4-a74d-47b4-952e-dcf5598b08e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69822-692-1069822069210325 TABLET in 1 BOTTLE (69822-692-10) 325 tablet2019-01-010000-00-00NoNoCurrent