FDA.reportPublic FDA data

Acetaminophen

Product NDC
49348-973
Requested package NDC
49348-973-10
11-digit product format
493480973
Labeler code
49348
Product ID
49348-973_ee9eab9e-ad98-57c2-e053-2a95a90a9531
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-12-13
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-97349348-973-10DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-97349348-973-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-973-10EA - Each49348-9738272bb6e-93f6-4ca2-82ca-97ae0df9684112014-05-02
49348-973-16EA - Each49348-97357cf5560-9dba-42c7-a98c-cb509a1d315012017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET, COATED [MCKESSON]1
AcetaminophenACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET, COATED [MCKESSON]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET, COATED [MCKESSON]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACETAMINOPHEN TABLET, COATED [MCKESSON]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET, COATED [MCKESSON]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN TABLET, COATED [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-973ACETAMINOPHEN TABLET, COATED [STRATEGIC SOURCING SERVICES LLC]6Legacy NDC20231031_ecb06efe-d4ac-4e3f-8cf1-b48a29970c7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNba4b33b3-e071-4b03-88a0-89dc85f616251
313782acetaminophen 325 MG Oral TabletSCDba4b33b3-e071-4b03-88a0-89dc85f616251
313782APAP 325 MG Oral TabletSYba4b33b3-e071-4b03-88a0-89dc85f616251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49348-973-10493480973101 BOTTLE, PLASTIC in 1 CARTON (49348-973-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2017-09-010000-00-00NoNoCurrent