Pain Relief

Product NDC
83324-078
11-digit product format
833240078
Labeler code
83324
Product ID
83324-078_458b4f7d-8f0c-2559-e063-6294a90a663b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-03
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
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
c57c10fc-f182-4153-8974-ef359a5f5ac1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-078-01Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
83324-078-01Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003
83324-078-05Pain ReliefExtra Strength500 in 1 BOTTLE, PLASTICTABLET, COATED5003
83324-078-15Pain ReliefExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED1503
83324-078-24Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
83324-078-24Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED243
83324-078-50Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
83324-078-50Pain ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-078-01EA - Each83324-0788ba5a904-64d3-4327-93d3-7e433d1e33c212026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-078PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 8 package rows20240615_c57c10fc-f182-4153-8974-ef359a5f5ac1.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 16 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain Relief Dye freeACTEMINOPHENBETTER LIVING BRANDS LLC.41f504d1-29c4-f075-e063-6394a90ad64c2026-04-11WarningsExact identifier
application number: M013
Dr. Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4f1e1f1a-44f4-2356-e063-6294a90a8cdd2026-04-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAkron Pharma Inc.e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed2026-04-10WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.28413cb3-22c4-40e2-ad6b-42beb438dea32026-04-10WarningsExact identifier
application number: M013
Pain Reliever ChildrensACETAMINOPHENH E B7e43de11-d20b-4920-a04d-3c1b5d35e0052026-04-09WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINNavajo Manufacturing Company Inc.f6f2ce71-5728-aefb-e053-6394a90a20e42026-04-08WarningsExact identifier
application number: M013
MidolACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATENavajo Manufacturing Company Inc.cabd10f2-a91e-4406-9249-915e306c867b2026-04-08WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc3730ee46-b241-44eb-94fa-52b9d12a9c352026-04-08WarningsExact identifier
application number: M013
AspirinASPIRINWalgreen Company82cc404b-fcf5-4e48-ab1a-09d8c47f9e042026-04-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC1b164780-ec84-4187-8afa-6f8a0da550fc2026-04-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreens6e7475e2-81a9-43b5-9b81-b58ab761a6f42026-04-07WarningsExact identifier
application number: M013
Pain Relief Aspirin Low DoseASPIRINRite Aid Corporation503408ed-e799-48a0-8d38-3034f4a0ead52026-04-02WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINLidl US LLC468f4a2f-60f7-4808-95d7-a00be1bb112f2026-04-02WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENGrocery Outlet, Inc.44de6f5a-0b5c-6c28-e063-6394a90a7e0b2026-04-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICE26ae0d0a-34c0-4d16-951a-8d5a463c808b2026-04-02WarningsExact identifier
application number: M013
Pain Reliever plus Sleep Aid NightTimeACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger Company286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d02026-04-02WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINCOSTCO WHOLESALE CORPORATIONc8a8986b-1ab4-9da0-71da-42595db08b442026-04-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc57c10fc-f182-4153-8974-ef359a5f5ac13
198440acetaminophen 500 MG Oral TabletSCDc57c10fc-f182-4153-8974-ef359a5f5ac13
198440APAP 500 MG Oral TabletSYc57c10fc-f182-4153-8974-ef359a5f5ac13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-078-01833240078011 BOTTLE, PLASTIC in 1 CARTON (83324-078-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-03NoNoCurrent
83324-078-0583324007805500 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-05) 2024-04-03NoNoCurrent
83324-078-1583324007815150 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-15) 2024-04-03NoNoCurrent
83324-078-24833240078241 BOTTLE, PLASTIC in 1 CARTON (83324-078-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-03NoNoCurrent
83324-078-50833240078501 BOTTLE, PLASTIC in 1 CARTON (83324-078-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-03NoNoCurrent