FDA.reportPublic FDA data

pain relief acetaminophen

Product NDC
11822-0519
11-digit product format
118220519
Labeler code
11822
Product ID
11822-0519_940fbb99-f563-43fe-bb35-0ca869fb8a6b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-10
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-051911822-0519-1DDiscontinued by firm2026-10-21

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 acetaminophen
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

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
11822-0519-1pain relief acetaminophenExtra Strength2 in 1 BLISTER PACKTABLET, COATED224
11822-0519-1pain relief acetaminophenExtra Strength1 in 1 CARTONTABLET, COATED124
11822-0519-2pain relief acetaminophenExtra Strength1 in 1 CARTONTABLET, COATED124
11822-0519-2pain relief acetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10024
11822-0519-3pain relief acetaminophenExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22524
11822-0519-5pain relief acetaminophenExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED5024
11822-0519-5pain relief acetaminophenExtra Strength1 in 1 CARTONTABLET, COATED124
11822-0519-8pain relief acetaminophenExtra Strength1 in 1 CARTONTABLET, COATED124
11822-0519-8pain relief acetaminophenExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED2424
11822-0519-9pain relief acetaminophenExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED15024

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [RITE AID]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0519PAIN RELIEF ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [RITE AID CORPORATION]23Current NDC, Legacy NDC, 10 package rows20240928_26c0641e-1cdd-4084-939d-01dbd36ab9b7.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 76 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC03d42892-4465-4089-90a7-cd5f00c356022023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC57bb1acc-b9a0-48cd-8e5c-33712441ce812023-11-29WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCcc0ab7a1-e535-4dc8-962f-c58949fc17372023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLCa4ff94b9-c248-4cd3-8491-38e9555cc22e2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCd59c5f04-4bcc-4a52-a42f-e049506f00de2023-11-29WarningsExact identifier
application number: M013
Aurophen Extra Strength for AdultsACETAMINOPHENAurohealth LLCa769094b-1e91-4ca7-ba67-21aa7e3129102023-11-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAurohealth LLC30756257-f748-4a5d-b031-dd267d0f91ad2023-11-29WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENAurohealth LLC8eda893f-5266-4b7a-95b9-2e194973cf062023-11-29WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC00ec6518-b5e3-49d1-a342-139381c3bfd22023-11-29WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEFACETAMINOPHENBetter Living Brands, LLCfadb4c09-071f-56c0-e053-6294a90ae6c12023-11-28WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsExact identifier
application number: M013
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
application number: M013
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
application number: M013
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
application number: M013
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENA-S Medication Solutions400d4a29-9e39-4e74-8272-37be5d7899242023-11-22WarningsExact identifier
application number: M013
RIGHT REMEDIES Pain Relief Extra Strength CapletACETAMINOPHENStrive Pharmaceuticals Inc.dcce28d9-8528-489e-b995-1d98e9d0e6ad2023-11-21WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN26c0641e-1cdd-4084-939d-01dbd36ab9b724
198440acetaminophen 500 MG Oral TabletSCD26c0641e-1cdd-4084-939d-01dbd36ab9b724
198440APAP 500 MG Oral TabletSY26c0641e-1cdd-4084-939d-01dbd36ab9b724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0519-1118220519011 BLISTER PACK in 1 CARTON (11822-0519-1) > 2 TABLET, COATED in 1 BLISTER PACK1 blister pack2004-05-100000-00-00NoNoCurrent
11822-0519-2118220519021 BOTTLE, PLASTIC in 1 CARTON (11822-0519-2) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
11822-0519-311822051903225 TABLET, COATED in 1 BOTTLE, PLASTIC (11822-0519-3) 2004-05-100000-00-00NoNoCurrent
11822-0519-5118220519051 BOTTLE, PLASTIC in 1 CARTON (11822-0519-5) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
11822-0519-8118220519081 BOTTLE, PLASTIC in 1 CARTON (11822-0519-8) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-10NoNoCurrent
11822-0519-911822051909150 TABLET, COATED in 1 BOTTLE, PLASTIC (11822-0519-9) 2004-05-100000-00-00NoNoCurrent