FDA.reportPublic FDA data

Pain Relief

Product NDC
63868-084
11-digit product format
638680084
Labeler code
63868
Product ID
63868-084_243531d9-3c42-d20a-e063-6294a90a2b09
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-13
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

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
63868-084-05Pain ReliefExtra Strength500 in 1 BOTTLE, PLASTICTABLET, COATED5005
63868-084-10Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1005
63868-084-10Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED15
63868-084-20Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1005
63868-084-20Pain ReliefExtra Strength2 in 1 CARTONTABLET, COATED25
63868-084-24Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED245
63868-084-24Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED15
63868-084-50Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED15
63868-084-50Pain ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-084-05EA - Each63868-084047c6c6e-26bd-41bb-8750-06ef044c203e12019-08-06
63868-084-10EA - Each63868-08499f880e3-f152-4275-b7f0-3d3c194853a412020-03-10
63868-084-24EA - Each63868-084cfc2bdbf-80de-46fe-a6cf-f67889886cc212020-04-20
63868-084-50EA - Each63868-0841714a893-18f4-4100-a4c5-afff5894cacf12018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-084PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]5Current NDC, Legacy NDC, 9 package rows20241013_68a52858-35c5-402a-8ceb-8d8a7c1e5f6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN68a52858-35c5-402a-8ceb-8d8a7c1e5f6c5
198440acetaminophen 500 MG Oral TabletSCD68a52858-35c5-402a-8ceb-8d8a7c1e5f6c5
198440APAP 500 MG Oral TabletSY68a52858-35c5-402a-8ceb-8d8a7c1e5f6c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-084-0563868008405500 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-084-05) 2014-06-130000-00-00NoNoCurrent
63868-084-10638680084101 BOTTLE, PLASTIC in 1 CARTON (63868-084-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2014-06-132026-08-31NoNoCurrent
63868-084-2063868008420100 in 1 BOTTLE, PLASTICHistorical
63868-084-24638680084241 BOTTLE, PLASTIC in 1 CARTON (63868-084-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2014-06-132026-08-31NoNoCurrent
63868-084-50638680084501 BOTTLE, PLASTIC in 1 CARTON (63868-084-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2014-06-132026-08-31NoNoCurrent