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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-08463868-084-10DDiscontinued by firm2026-10-20
excluded packagepackage63868-08463868-084-20DDiscontinued by firm2026-10-20
excluded packagepackage63868-08463868-084-24DDiscontinued by firm2026-10-20
excluded packagepackage63868-08463868-084-50DDiscontinued by firm2026-10-20

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Pain Relief
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

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
68a52858-35c5-402a-8ceb-8d8a7c1e5f6cAvailable on FDA.report

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

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 61 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWalgreen Company9e08eb38-7538-4fa0-a0e1-047ab6cb16802024-10-15WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPUBLIX SUPER MARKETS INC9e779cc6-4641-6132-e053-2a95a90a34932024-10-11WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENCHAIN DRUG CONSORTIUM5c1a3081-ae25-4895-bf76-ebcbb9fc80722024-10-11WarningsExact identifier
application number: M013
Aspirin 81 MGASPIRINMeijerb3e5711c-9529-4eec-871d-de8efa858b862024-10-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INC9586e830-a285-4a07-8b34-9698754423482024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association68a52858-35c5-402a-8ceb-8d8a7c1e5f6c2024-10-11WarningsExact identifier
application number: M013
ndc (product): 63868-084
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association5de40821-3218-4320-bf11-9493bf01d4892024-10-11WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association475becec-1a56-4cfa-a0c5-562f8772adfb2024-10-11WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENTopco Associates LLC6036c15b-1168-4103-9471-6a74a2140e532024-10-10WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
application number: M013
dg health aspirinASPIRINDolgencorp, LLC0ab34dc7-0110-4fc3-ae53-234e7d7bca3c2024-10-07WarningsExact identifier
application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.19ba1fb6-22ea-488e-9e52-94c14ceb80d12024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINStrategic Sourcing Services LLC4d66a8a8-a1c1-4430-8845-21ae67700c392024-10-07WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderca603b12-e0f7-4d79-8e0d-4651a788ba9b2024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINMcKesson Medical-Surgical, Inc.e9342478-93d6-45de-948f-f4162ee675b22024-10-07WarningsExact identifier
application number: M013
Maximum Strength Backache ReliefMAGNESIUM SALICYLATEJHK DBA American Safety & First Aidf8cbcd4e-cfad-4592-8774-52e681494c452024-10-07WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORNavajo Manufacturing Company Inc.f70875ab-241c-4876-e053-6294a90a80922024-10-03WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.86b6ac01-3866-4cd8-a1be-9babb6ff311b2024-10-02WarningsExact identifier
application number: M013

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, PLASTIC2014-06-130000-00-00NoNoCurrent
63868-084-2063868008420100 in 1 BOTTLE, PLASTICHistorical
63868-084-24638680084241 BOTTLE, PLASTIC in 1 CARTON (63868-084-24) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC2014-06-130000-00-00NoNoCurrent
63868-084-50638680084501 BOTTLE, PLASTIC in 1 CARTON (63868-084-50) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC2014-06-130000-00-00NoNoCurrent