FDA.reportPublic FDA data

Extra Strength Pain Reliever

Product NDC
29485-9281
11-digit product format
294859281
Labeler code
29485
Product ID
29485-9281_1b444ae7-1662-e4ba-e063-6394a90a1f4e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500 mg
Dosage form
TABLET
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-17
Marketing end
2027-06-18
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
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
Extra Strength Pain Reliever

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
ee8e0e79-4da4-101f-e053-2a95a90a30a4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-9281-2Extra Strength Pain Reliever25 in 1 BOXTABLET255
29485-9281-2Extra Strength Pain Reliever2 in 1 POUCHTABLET25
29485-9281-3Extra Strength Pain Reliever2 in 1 POUCHTABLET25
29485-9281-3Extra Strength Pain Reliever30 in 1 BOXTABLET305
29485-9281-4Extra Strength Pain Reliever2 in 1 POUCHTABLET25
29485-9281-4Extra Strength Pain Reliever50 in 1 BOXTABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-9281EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN 500 MG) TABLET [LIL' DRUG STORE PRODUCTS, INC.]5Current NDC, Legacy NDC, 6 package rows20240621_ee8e0e79-4da4-101f-e053-2a95a90a30a4.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 30 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bayer Rapid ReliefASPIRIN/CAFFEINE ORAL POWDERBayer HealthCare LLC.f1fecbb0-5b55-fe8f-e053-2995a90a09772025-12-05WarningsExact identifier
application number: M013
Headache Relief, Extra Strength 24/7 Life by 7-ElevenACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATEDLil' Drug Store Products, Inc.45381b1c-2acd-1524-e063-6394a90a83d92025-12-05WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI729132cd-f209-447a-8949-a90b5a5c01da2025-12-05WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp05fda811-d65f-41b2-89e4-297cdddb3d992025-12-05WarningsExact identifier
application number: M013
aspirinASPIRINHealth Pharma USA, LLC3165b0a3-556b-6abe-e063-6394a90a76822025-12-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINBayer HealthCare LLC.44a08904-68b9-4d06-a28d-21aae3d6140c2025-12-04WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a29dde6-a177-6206-e053-2991aa0a01f22025-12-04WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp7570aaa2-3238-4cd3-b788-915caa970dba2025-12-04WarningsExact identifier
application number: M013
Bayer HeadacheASPIRIN AND CAFFEINEBayer HealthCare LLC.c0a92873-0914-6a86-e053-2995a90ac41c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORBayer HealthCare LLC.07478020-5ba0-3b67-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.0dba1329-5b0d-5688-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Cold Medicine Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.78537dcf-b157-4b67-a8b2-5cb1448151662025-12-04WarningsExact identifier
application number: M013
BAYER Aspirin Extra Strength CapletsBAYER ASPIRIN EXTRA STRENGTHBayer HealthCare LLC.0ae64cdb-4ea0-23af-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry FlavoredASPIRINBayer HealthCare LLC.070d5713-e018-2913-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Bayer Low DoseASPIRINBayer HealthCare LLC.075b103e-0bb4-4b7a-ac0e-5645bcbd0a072025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
application number: M013
Bayer Aspirin Regimen enteric coatedASPIRINBayer HealthCare LLC.0c6ae05f-7634-34d1-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
aspirin pain reliefASPIRINRite Aid Corporationae9d9977-7576-4894-8a32-454828abec9a2025-12-04WarningsExact identifier
application number: M013
ASPIRINASPIRINRMT HEALTH LLC2bacffd1-4870-73af-e063-6294a90a19c82025-12-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINERite Aid Corporationd9caee45-be43-45ec-927f-e7fec5c14f072025-12-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNee8e0e79-4da4-101f-e053-2a95a90a30a45
198440acetaminophen 500 MG Oral TabletSCDee8e0e79-4da4-101f-e053-2a95a90a30a45
198440APAP 500 MG Oral TabletSYee8e0e79-4da4-101f-e053-2a95a90a30a45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29485-9281-22948592810225 POUCH in 1 BOX (29485-9281-2) / 2 TABLET in 1 POUCH25 pouch2017-01-172027-06-18NoNoHistorical
29485-9281-32948592810330 POUCH in 1 BOX (29485-9281-3) / 2 TABLET in 1 POUCH30 pouch2017-01-172027-06-18NoNoCurrent
29485-9281-42948592810450 POUCH in 1 BOX (29485-9281-4) / 2 TABLET in 1 POUCH50 pouch2017-01-172027-02-05NoNoHistorical