FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
82568-0002
11-digit product format
825680002
Labeler code
82568
Product ID
82568-0002_34157f6a-3032-4388-e063-6394a90a670f
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
AARNA USA INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-15
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
ACETAMINOPHEN
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
34157f6a-3031-4388-e063-6394a90a670fAvailable 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
82568-0002-1ACETAMINOPHEN100 in 1 BOTTLETABLET1001
82568-0002-2ACETAMINOPHEN1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0002-1EA - Each82568-0002e252ee47-500b-4edb-82d4-b126ef91b5e912025-07-08
82568-0002-2EA - Each82568-0002fa6dc4e5-951a-4878-968a-9f8ccee927c212025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0002ACETAMINOPHEN TABLET [AARNA USA INC.]1Current NDC, 2 package rows20250515_34157f6a-3031-4388-e063-6394a90a670f.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 55 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5c42dd28-820c-4cc5-9016-11ad5e5806162024-11-25WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.4518fe82-3ba8-4e9e-a036-776df7fb8d572024-11-21WarningsExact identifier
application number: M013
Family Wellness Pain RelieverASPIRINFAMILY WELLNESS SERVICES, INC.075e19f4-1a58-aedd-e063-6294a90af7082024-11-20WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
application number: M013
Temp XACETAMINOPHENOPMX Chula Vistafd2edc32-0351-c991-e053-6294a90ab4ce2024-11-15WarningsExact identifier
application number: M013
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
application number: M013
Walgreens Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreens667418fc-a3ab-cbc7-e053-2a91aa0a20232024-11-13WarningsExact identifier
application number: M013
Up and Up Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETarget Corporationa72eef45-b985-638a-e053-2995a90aa20a2024-11-13WarningsExact identifier
application number: M013
Signature Care Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATESafeway, Inc6e120024-475a-73af-e053-2a91aa0a42a62024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Kroger Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEKroger Company6d858b0e-a3c8-2686-e053-2991aa0acc062024-11-13WarningsExact identifier
application number: M013
TopCare Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETopco Associates LLC639f9d57-f26a-708a-e053-2a91aa0a69622024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company6418cde9-607b-4ca1-e053-2991aa0a91702024-11-13WarningsExact identifier
application number: M013
Bromo SeltzerASPIRIN, SODIUM BICARBONATE, CITRIC ACIDTower Laboratories Ltd8ff88ee1-e33e-4051-992f-24e2720c48ce2024-11-13WarningsExact identifier
application number: M013
Care One Original Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEFoodhold U.S.A.8f662c51-d2fa-6458-e053-2995a90ac6fd2024-11-13WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefAPIRIN, CITRIC ACID, SODIUM BICARBONATETower Laboratories Ltd43c7f435-735c-3fab-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
DG Health Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDOLGENCORP, INC8f1343d5-2884-3a14-e053-2a95a90a2f902024-11-13WarningsExact identifier
application number: M013
Good Sense Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEGood Sensecd25b0c3-0134-beef-e053-2a95a90a092b2024-11-13WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDiscount Drug Mart, Inc8bc65603-1dbf-30ab-e053-2995a90a7c152024-11-13WarningsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Company8aab905b-5fe7-dddb-e053-2995a90a6c6f2024-11-13WarningsExact identifier
application number: M013
Publix Fast Relief EffervescentASPIRIN, CITRIC ACID, SODIUM BICARBONATEPublix Super Markets Inc.73051f16-2569-7394-e053-2991aa0a53592024-11-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN34157f6a-3031-4388-e063-6394a90a670f1
198440acetaminophen 500 MG Oral TabletSCD34157f6a-3031-4388-e063-6394a90a670f1
198440APAP 500 MG Oral TabletSY34157f6a-3031-4388-e063-6394a90a670f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0002-182568000201100 TABLET in 1 BOTTLE (82568-0002-1) 100 tablet2025-05-15NoNoCurrent
82568-0002-2825680002021000 TABLET in 1 BOTTLE (82568-0002-2) 1000 tablet2025-05-15NoNoCurrent