FDA.reportPublic FDA data

Clear Choice Regular Strength Pain Reliever

Product NDC
53185-005
Requested package NDC
53185-005-00
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 49 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENMajor Pharmaceuticals38b839b6-de7d-4f33-a19a-efc92cdad92c2025-01-24WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENPreferred Pharmaceuticals Inc.523b68da-cd2a-4960-95e7-de5d51ce33c12025-01-23WarningsExact identifier
application number: M013
Safety Coated Aspirin 81 mg Low DoseASPIRIN 81MGUlai Health LLC3d225a11-a53b-4dc2-9c25-13cab007900f2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 325 MGUlai Health LLC55bb7e6c-e98c-48bd-b7bb-9848ff0273ca2025-01-20WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MGUlai Health LLCd4a568c9-a721-48d1-aebc-fc65444947ce2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCc9d3cee1-531c-439f-ae19-07acd366aad62025-01-20WarningsExact identifier
application number: M013
Percogesic Original StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLMedtech Products Inc.529974c2-0121-4892-8e47-c2c4475810912025-01-17WarningsExact identifier
application number: M013
Little Remedies Childrens Fever Pain RelieverACETAMINOPHENMedtech Products Inc.e1e44c85-d10c-4997-8f85-064cda7906eb2025-01-17WarningsExact identifier
application number: M013
StanbackASPIRIN AND CAFFEINEMedtech Products Inc.caaa1313-09e4-45aa-8836-346f6a3701962025-01-17WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPrecision Dose Inc.5cc698fa-0841-4851-ae21-0aac8b40eb0a2025-01-16WarningsExact identifier
application number: M013
EcotrinASPIRINMedtech Products Inc.222d187b-aae6-410b-baeb-b2bd42f5c6762025-01-16WarningsExact identifier
application number: M013
Children Pain and Fever RelieverACETAMINOPHENTarget Corporation0dd643a4-3cbc-423d-95b4-ba373b09d8952025-01-16WarningsExact identifier
application number: M013
Chewable Low Dose AspirinASPIRINTARGET CORPORATIONf934e72a-2e9f-da17-e053-6394a90a1a2e2025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENReliable 1 Laboratories LLC2651bf11-4d66-43ba-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRIN 325MGUlai Health LLC26942d32-d6e6-464d-8fc4-ffd9806d3e622025-01-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INCa354b24e-0913-829f-e053-2995a90ad4072025-01-11WarningsExact 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