FDA.reportPublic FDA data

Extra Strength Pain Relief

Product NDC
57896-201
11-digit product format
578960201
Labeler code
57896
Product ID
57896-201_4525a8f8-b8bd-c290-e063-6394a90a81d9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-01-01
Marketing end
2026-11-30
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57896-20157896-201-01DDiscontinued by firm2026-10-15
excluded packagepackage57896-20157896-201-05DDiscontinued by firm2026-10-15

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0557896-201-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0557896-201-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2657896-201-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2657896-201-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3157896-201-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3157896-201-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2857896-201-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2857896-201-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2157896-201-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2157896-201-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1057896-201-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1057896-201-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3157896-201-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3157896-201-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2057896-201-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2057896-201-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1057896-201-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1057896-201-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0857896-201-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0857896-201-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0357896-201-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0357896-201-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0957896-201-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0957896-201-01557ba5c1ecfa…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
Extra Strength Pain Relief

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
7570aaa2-3238-4cd3-b788-915caa970dbaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-201-01Extra Strength Pain Relief100 in 1 BOTTLETABLET1007
57896-201-05Extra Strength Pain Relief50 in 1 BOTTLETABLET507
57896-201-10Extra Strength Pain Relief1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-201-01EA - Each57896-20182dbdfae-7cce-45e7-bf0c-c214686bb89612012-07-24
57896-201-05EA - Each57896-2015d0770cd-70c2-4757-896d-62e868f751c012022-06-06
57896-201-10EA - Each57896-201aa5f4c60-e670-45f2-861b-c2ad8e686e2a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
POVIDONEINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1000
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
AcetaminophenACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
AcetaminophenACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-201EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 3 package rows20240705_7570aaa2-3238-4cd3-b788-915caa970dba.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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN31a97a6a-e5c8-429a-b497-330f0d84777d1007
198440acetaminophen 500 MG Oral TabletSCD31a97a6a-e5c8-429a-b497-330f0d84777d1007
198440APAP 500 MG Oral TabletSY31a97a6a-e5c8-429a-b497-330f0d84777d1007
198440acetaminophen 500 MG Oral TabletPSNa32f346e-71d0-cc11-e053-2a95a90ae88c7
198440acetaminophen 500 MG Oral TabletPSN7570aaa2-3238-4cd3-b788-915caa970dba7
198440acetaminophen 500 MG Oral TabletSCDa32f346e-71d0-cc11-e053-2a95a90ae88c7
198440acetaminophen 500 MG Oral TabletSCD7570aaa2-3238-4cd3-b788-915caa970dba7
198440APAP 500 MG Oral TabletSYa32f346e-71d0-cc11-e053-2a95a90ae88c7
198440APAP 500 MG Oral TabletSY7570aaa2-3238-4cd3-b788-915caa970dba7
198440acetaminophen 500 MG Oral TabletPSNc70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2
198440acetaminophen 500 MG Oral TabletPSN39580eb4-50dd-4381-a00f-359c68ce1cb42
198440acetaminophen 500 MG Oral TabletSCDc70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2
198440acetaminophen 500 MG Oral TabletSCD39580eb4-50dd-4381-a00f-359c68ce1cb42
198440APAP 500 MG Oral TabletSY39580eb4-50dd-4381-a00f-359c68ce1cb42
198440APAP 500 MG Oral TabletSYc70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2
198440acetaminophen 500 MG Oral TabletPSN33376625-3cc2-4bf2-9009-a3e728f4b8f51
198440acetaminophen 500 MG Oral TabletPSN31ce5c80-152f-12a1-e063-6394a90ab1191
198440acetaminophen 500 MG Oral TabletSCD33376625-3cc2-4bf2-9009-a3e728f4b8f51
198440acetaminophen 500 MG Oral TabletSCD31ce5c80-152f-12a1-e063-6394a90ab1191
198440APAP 500 MG Oral TabletSY33376625-3cc2-4bf2-9009-a3e728f4b8f51
198440APAP 500 MG Oral TabletSY31ce5c80-152f-12a1-e063-6394a90ab1191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-201-0157896020101100 TABLET in 1 BOTTLE (57896-201-01) 100 tablet2012-01-010000-00-00NoNoCurrent
57896-201-055789602010550 TABLET in 1 BOTTLE (57896-201-05) 50 tablet2012-01-010000-00-00NoNoCurrent
57896-201-10578960201101000 TABLET in 1 BOTTLE (57896-201-10) 1000 tablet2012-01-012026-11-30NoNoCurrent
57896-201-20578960201201 TABLET in 1 BOTTLE (57896-201-20) 1 tablet2022-11-010000-00-00NoNoCurrent