Pain Relief

Product NDC
83324-081
11-digit product format
833240081
Labeler code
83324
Product ID
83324-081_1ac6e721-4d0a-0396-e063-6294a90a7fe9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-26
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
cfaf9495-e654-4dfc-ba23-d2358c3720c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-081-01Pain ReliefExtra Strength100 in 1 PACKAGETABLET1002
83324-081-01Pain ReliefExtra Strength1 in 1 CARTONTABLET12
83324-081-10Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET1002
83324-081-60Pain ReliefExtra Strength60 in 1 BOTTLE, PLASTICTABLET602
83324-081-60Pain ReliefExtra Strength1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-081-01EA - Each83324-081e54beb91-3e2c-4ee4-93be-0ea7ee0c454a12026-01-08
83324-081-10EA - Each83324-0812b7a8e0d-06af-48b6-9c17-b2bd7bccc12112026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-081PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2Current NDC, 5 package rows20240615_cfaf9495-e654-4dfc-ba23-d2358c3720c4.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 78 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81mg Enteric coated Low Strength Aspirin RegimenASPIRINAllegiant Health847fd2f8-2e32-4ef2-a793-b902045110f12021-11-19WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINAllegiant Healthd6c7c8c9-b997-4acc-a066-133bfb1239cb2021-11-02WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINDr. Wayne'seacbdf9e-5642-4986-a03c-b0812d28265d2021-11-02WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin RegimenASPIRINAllegiant Healthd9abe780-7e58-43d8-848f-c6c8893aea2e2021-10-14WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500MGAllegiant Health0f72be92-fac0-4be4-87a3-3f20f0f01db52021-05-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health8cacf02c-9925-40d4-92bc-78788aa0681a2020-11-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
application number: M013
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
application number: M013
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
application number: M013
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
application number: M013
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
application number: M013
Aspirin ChewableASPIRIN 81 MGAllegiant Health92b8637b-03a9-461f-b2f6-6eddaa2149532018-12-21WarningsExact identifier
application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
application number: M013
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
application number: M013
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
application number: M013
AspirinASPIRIN 325 MGAllegiant Health88b54062-8b3d-4024-a957-62b3255184b92018-11-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNcfaf9495-e654-4dfc-ba23-d2358c3720c42
198440acetaminophen 500 MG Oral TabletSCDcfaf9495-e654-4dfc-ba23-d2358c3720c42
198440APAP 500 MG Oral TabletSYcfaf9495-e654-4dfc-ba23-d2358c3720c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-081-01833240081011 PACKAGE in 1 CARTON (83324-081-01) / 100 TABLET in 1 PACKAGE1 package2024-04-26NoNoCurrent
83324-081-1083324008110100 TABLET in 1 BOTTLE, PLASTIC (83324-081-10) 100 tablet2024-06-12NoNoCurrent
83324-081-60833240081601 BOTTLE, PLASTIC in 1 CARTON (83324-081-60) / 60 TABLET in 1 BOTTLE, PLASTIC2024-04-26NoNoCurrent