Extra Strength Pain Relief

Product NDC
57896-251
11-digit product format
578960251
Labeler code
57896
Product ID
57896-251_08157e2c-2c6f-1487-e063-6394a90a1092
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-06-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Extra Strength Pain Relief
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
198439Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e65dbd01-2d5e-4067-ad98-98d879cfb5eeAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-251-012021-02-11C16284748780-1ba0f9c33-173a-a910-e053-dadaa90a0b85251
57896-251-012021-01-29C16284748780-1ba0f9c33-173a-a910-e053-dadaa90a0b85251

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-251-01Extra Strength Pain Relief100 in 1 BOTTLECAPSULE, GELATIN COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-251-01EA - Each57896-2516c3d4970-d52c-41c9-b411-76520f2292ad12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
GELATININACTIVE INGREDIENT2G86QN327LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-251EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 1 package rows20231020_e65dbd01-2d5e-4067-ad98-98d879cfb5ee.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 23 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINHYVEE INC3e602287-565e-a5b9-e063-6294a90abc172026-01-13WarningsExact identifier
application number: M013
ASPIRIN DELAYED RELEASE 81MGASPIRIN DELAYED RELEASE 81MGFarmacias De Similares TX LLC3a8a3efc-f0b3-411c-e063-6394a90a84b72026-01-13WarningsExact identifier
application number: M013
Chewable Aspirin 81 mgASPIRINHYVEE INC459f749f-9d23-8752-e063-6394a90a8c812026-01-13WarningsExact identifier
application number: M013
ASPIRIN 325 mgASPIRINHYVEE INC459d01df-6ff6-cff6-e063-6394a90ab35c2026-01-13WarningsExact identifier
application number: M013
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
application number: M013
Aspirin PacksASPIRINSina Health Inc2865a2c3-53fc-ab9a-e063-6394a90a14182026-01-12WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.64696f65-415e-4ce1-a5b3-70662fbcb0022026-01-12WarningsExact identifier
application number: M013
Aspirin enteric coated low doseASPIRINWalgreen Company186a6270-e3de-4499-88a4-5f723fee3e342026-01-12WarningsExact identifier
application number: M013
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINFamily Dollar Services Incd35d798e-76f1-454d-86f6-ad11c3bf17d82026-01-12WarningsExact identifier
application number: M013
Xpect AcetaminophenACETAMINOPHENCintas Corporationf4aed854-730e-493d-b523-122156e08dde2026-01-09WarningsExact identifier
application number: M013
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
application number: M013
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
application number: M013
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergenc3099892-a8cd-4574-a6f9-041e59e2feae2026-01-07WarningsExact identifier
application number: M013
Bactimicina Childrens Pain and FeverACETAMINOPHENDLC Laboratories, Inc.bdade270-d813-4178-b594-4951632b68392026-01-07WarningsExact identifier
application number: M013
Goodmeds Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.02c60967-46d7-49b7-82be-bc3c5fd364842026-01-06WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEa73f8217-9eae-4e2a-b29c-7de3861d0e372026-01-06WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporationf77f0120-4042-4b11-ba9c-cd35e1cd0bee2026-01-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198439acetaminophen 500 MG Oral CapsulePSNe65dbd01-2d5e-4067-ad98-98d879cfb5ee5
198439acetaminophen 500 MG Oral CapsuleSCDe65dbd01-2d5e-4067-ad98-98d879cfb5ee5
198439APAP 500 MG Oral CapsuleSYe65dbd01-2d5e-4067-ad98-98d879cfb5ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-251-0157896025101100 CAPSULE, GELATIN COATED in 1 BOTTLE (57896-251-01) 2012-11-010000-00-00NoNoCurrent