FDA.reportPublic FDA data

Pain Relief

Product NDC
63868-082
11-digit product format
638680082
Labeler code
63868
Product ID
63868-082_7e490b7b-e77c-5917-e053-2991aa0a3d17
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-13
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct63868-082DDiscontinued by firm2026-10-05
excluded packagepackage63868-08263868-082-10DDiscontinued 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
63868-082-10Pain ReliefRegular Strength100 in 1 BOTTLE, PLASTICTABLET1003
63868-082-10Pain ReliefRegular Strength1 in 1 CARTONTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-082-10EA - Each63868-082e039c65c-7a71-4ab2-a862-0b4ddcbd9cca12019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-082PAIN RELIEF REGULAR STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]3Legacy NDC, 2 package rows20241013_89c42e1a-db09-4558-a464-7f484ab16508.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN89c42e1a-db09-4558-a464-7f484ab165083
313782acetaminophen 325 MG Oral TabletSCD89c42e1a-db09-4558-a464-7f484ab165083
313782APAP 325 MG Oral TabletSY89c42e1a-db09-4558-a464-7f484ab165083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-082-10638680082101 BOTTLE, PLASTIC in 1 CARTON (63868-082-10) > 100 TABLET in 1 BOTTLE, PLASTIC2014-06-130000-00-00NoNoCurrent