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 74 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2560126e-a54a-4a47-9631-a1bca42f52772024-01-10WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINA-S Medication Solutionsee4451c9-4d0f-4373-8f64-fcc1f9dd58562024-01-05WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP51ba690e-d76b-41c6-a083-8bc803e1faa22024-01-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-Aspirin Extra StrengthACETAMINOPHENProficient Rx LP9071b047-5463-4f65-b775-bfb0ce0665272024-01-01WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
application number: M013
MAX Cold, Flu, and Sore ThroatACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCLH E B9b09b660-0758-48dc-84c9-26cdd2aacc032023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRYACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.e6c3e545-b2ad-47f0-8318-c134a8e24f5b2023-12-29WarningsExact identifier
application number: M013
Daytime Non-Drowsy COLD/FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESalado Sales, Inc.e181b371-78c7-4163-865d-acc064be33ca2023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever Cherry flavorACETAMINOPHENWalgreen Company64c65244-f7a3-401b-b83a-bf66d45268e22023-12-29WarningsExact identifier
application number: M013
Nite-Time COLD/FLU ORIGINALACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESalado Sales, Inc.fcd24753-b42b-4d05-8379-0ec0351ab2172023-12-29WarningsExact identifier
application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU CherryACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Baskete772cdf5-d01d-4752-8cfb-7e7f4d7a8dd02023-12-29WarningsExact identifier
application number: M013
Childrens Pain and Fever, Grape flavorACETAMINOPHENWalgreen Company0995d69f-61aa-40b0-b095-bb8595caf7732023-12-29WarningsExact identifier
application number: M013
DAY-TIME Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketce900e42-d0c8-408d-a1c3-3a9bef1c97ee2023-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLDOLGENCORP, INC.06553550-5685-f3c3-e063-6394a90aef072023-12-22WarningsExact identifier
application number: M013
Tension Headache Pain Relieving AidACETAMINOPHEN,CAFFEINEWAL-MART STORES INC00fadd26-a6eb-dc5e-e063-6394a90a3cca2023-12-15WarningsExact identifier
application number: M013
Dye-Free Aspirin 81ASPIRINWALGREENSd71a9d3a-cd28-14a8-e053-2995a90a832b2023-12-15WarningsExact identifier
application number: M013
Lil Drug Store Aspirin 325ASPIRINLil Drug Store Products, Incde59aae2-f794-4243-acc8-37a10e27abde2023-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN TABLET, EXTRA STRENGTHLil' Drug Store Products, Inc.f0fdab5a-9d07-57aa-e053-2a95a90adc7f2023-12-15WarningsExact identifier
application number: M013
BC CherryASPIRIN AND CAFFEINELil' Drug Store Products, Inc79ea721b-d656-44f7-9d13-390debee7be02023-12-15WarningsExact 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