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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
application number: M013
CHILDRENS AcetaminophenCHILDRENS ACETAMINOPHENKesin Pharma Corporation4af5b025-1fd7-e825-e063-6294a90aa0052026-02-16WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC4a121a53-dbae-05c7-e063-6294a90aed892026-02-13WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.562d7901-44d6-4d9b-be8b-a8d468a22c432026-02-13WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENMajor Pharmaceuticals020fa486-31f0-4e0c-84d3-5b3aaded1eeb2026-02-13WarningsExact identifier
application number: M013
ASPIRIN Low StrengthASPIRINCVS Pharmacy6e1c1129-562b-4a8a-ac37-db3cb2a827352026-02-11WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3dd21aaf-13b2-9e81-e063-6294a90afaec2026-02-11WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC2e31fe65-5f50-455b-99fa-c72879f435452026-02-10WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENAmerisource Bergen9ea8bb1f-1924-4430-98bd-f2674d0da7482026-02-09WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd4a61313e-1b48-29df-e063-6394a90a27f02026-02-09WarningsExact identifier
application number: M013
good sense aspirinASPIRINL. Perrigo Companye9fddbc1-11fe-4cf6-8794-1650fa1b32ae2026-02-07WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.2d375ec9-a528-4048-a15b-652fa20e74a72026-02-06WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINSportpharm LLCd3379569-7949-4f78-b634-5d4178b21ea42026-02-06WarningsExact identifier
application number: M013
Buffered AspirinASPIRINCardinal Health 110, LLC. DBA Leadere5f68c1a-21f3-45a1-861f-229a95b3721c2026-02-06WarningsExact identifier
application number: M013
pain relief extra strengthACETAMINOPHENHyVee Inc1e707628-08b1-4c72-b71c-2b4ae96071f22026-02-06WarningsExact identifier
application number: M013
CareOne Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerican Sales Company2d2ded37-f241-4976-886d-5c038a85bfe12026-02-05WarningsExact identifier
application number: M013
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
application number: M013
Alka-Seltzer Extra Strength Pain ReliefANHYDROUS CITRIC ACID, ASPIRINBayer HealthCare LLC.4a16b6e5-f0c6-e3a4-e063-6294a90a85ad2026-02-05WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYb8ab85a6-3eab-4ef4-a13d-5ac300480f632026-02-03WarningsExact 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