FDA.reportPublic FDA data

Clear Choice Regular Strength Pain Reliever

Product NDC
53185-005
11-digit product format
531850005
Labeler code
53185
Product ID
53185-005_07a99067-4ec1-49f8-8982-620e6efb78c5
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Athlete's Needs, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-03
Substance
ACETAMINOPHEN
Active strength
325 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
Clear Choice Regular Strength Pain Reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 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
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53185-005-00Clear Choice Regular Strength Pain Reliever100 in 1 BOTTLETABLET1009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DREGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DREGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AREGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJREGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53185-005CLEAR CHOICE REGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [ATHLETE'S NEEDS, INC.]9Current NDC, Legacy NDC, 1 package rows20241109_d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7.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 72 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC691b754c-bafc-47e2-a322-cf56245c01f62024-03-14WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INCfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2024-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2cde052d-22a4-470f-8d6a-7c17061b8ac82024-03-14WarningsExact identifier
application number: M013
Excedrin Tension HeadacheACETAMINOPHEN, CAFFEINEHaleon US Holdings LLC12c074d1-81ac-47d2-8747-b018cda0058a2024-03-13WarningsExact identifier
application number: M013
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEStrive Pharmaceuticals Inc.78c12459-3b27-4ed0-943d-520794eb438d2024-03-07WarningsExact identifier
application number: M013
Pain Reliever fever Reducer Extra StrengthACETAMINOPHENCVS Pharmacy7b5263ad-01b7-4fc5-9384-4da8efe89e352024-03-06WarningsExact identifier
application number: M013
Excedrin Extra Strength GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLC11a8439b-0159-4351-b0f5-fe7fad6a33c02024-03-05WarningsExact identifier
application number: M013
Winco Foods Effervescent Pain ReliefASPIRINWinco Foods, LLC128afdd7-a9d1-8957-e063-6294a90af5692024-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINCare One (Retail Business Services, LLC.)6659e103-fa03-4de0-af42-d2fbd548a87c2024-03-05WarningsExact identifier
application number: M013
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
application number: M013
SEDALMEX FORTEACETAMINOPHEN, ASPIRIN, CAFFEINEBelmora LLC33b3508e-4caa-4d05-9b15-cb82a2ee2d4d2024-02-28WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAMERISOURCE BERGEN2b923a97-836c-4dac-a8c0-3047a35fb62e2024-02-23WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBJWC (Berkley & Jensen / BJ's)b20a08f3-c9c0-4bd9-8ce0-acb932b5bb862024-02-22WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
application number: M013
Publix Fast Relief Effervescent - Original FlavorASPIRINPUBLIX SUPER MARKETS INC.0a342f72-45fd-3e12-e063-6394a90ae33e2024-02-16WarningsExact identifier
application number: M013
Equaline Effervescent Pain RelieverASPIRINUNITED NATURAL FOODS, INC. DBA UNFI0761299a-e913-7665-e063-6394a90a60032024-02-16WarningsExact identifier
application number: M013
TopCare Effervescent Pain ReliefASPIRINTOPCO ASSOCIATES LLC075f36e1-110c-e839-e063-6294a90a89d72024-02-16WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLCe1799765-c247-42b4-ad6a-8ba7d136abf22024-02-06WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCf626ab17-01c9-4493-ba9e-0c8c111463842024-02-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNd0d9fda5-5eba-4d51-b505-e93a2ae0bdd79
313782acetaminophen 325 MG Oral TabletSCDd0d9fda5-5eba-4d51-b505-e93a2ae0bdd79
313782APAP 325 MG Oral TabletSYd0d9fda5-5eba-4d51-b505-e93a2ae0bdd79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53185-005-0053185000500100 TABLET in 1 BOTTLE (53185-005-00) 100 tablet2013-06-030000-00-00NoNoCurrent