FDA.reportPublic FDA data

Pain Relief

Product NDC
37808-980
11-digit product format
378080980
Labeler code
37808
Product ID
37808-980_47074aaf-86d0-4a94-afc0-123353ba293b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
H E B
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-06-15
Substance
ACETAMINOPHEN
Active strength
500 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
Pain Relief
Listing expiration
2026-12-31

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
add6952e-9dd5-487c-93e6-337e9d6a4872Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-980-62Pain Relief24 in 1 BOTTLETABLET2446
37808-980-62Pain Relief1 in 1 CARTONTABLET146

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-980PAIN RELIEF (ACETAMINOPHEN) TABLET [H E B]46Current NDC, Legacy NDC, 2 package rows20241102_add6952e-9dd5-487c-93e6-337e9d6a4872.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 12 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutions92559d65-f5e2-4054-9763-b9c560452dab2026-05-22WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.441d2629-3fff-0bf1-e063-6394a90aa9b62026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d1bde-d677-fab7-e063-6394a90aaad42026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d3a39-cc55-3c7c-e063-6394a90ad7a72026-05-21WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLCb3f57af5-661f-4534-9eed-76e431f338db2026-05-20WarningsExact identifier
application number: M013
Good Sense aspirinASPIRINL. Perrigo Companye150dd59-8db8-449f-9c9a-1aa6deb3be2e2026-05-20WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLCe837538d-0515-4f99-b04c-fda63b28777e2026-05-20WarningsExact identifier
application number: M013
Walgreens Headache Relief Extra StrengthACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MGWalgreens52109b65-3bf1-de38-e063-6394a90a97272026-05-18WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.5220a40d-4a4f-5bad-e063-6394a90a93b02026-05-18WarningsExact identifier
application number: M013
childrens Pain and FeverACETAMINOPHENTopco Associates, LLC7f7b4377-9b40-4a12-808b-f1cd7d241b0d2026-05-18WarningsExact identifier
application number: M013
Aspirin Enteric Coated, Regular StrengthASPIRINGendose Pharmaceuticals, LLC10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa2026-05-15WarningsExact identifier
application number: M013
AspirinASPIRINGendose Pharmaceuticals, LLC119de26f-cce5-401c-81fa-775ebebf6c6f2026-05-15WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINCardinal Health 107, LLC827bbe77-febb-4352-892f-3fbb2acfc7d52026-05-14WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC56c125de-fabf-41fa-88a4-760d2793f2022026-05-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEChain Drug Marketing Association, Inc.17216bf3-bed0-4d7a-994e-76a0e4c79c5c2026-05-13WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutionsc445c6bb-69a8-492e-b100-ce942707f2032026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Company1754a9f2-e7e5-4efb-a728-6ba2a7155d112026-05-12WarningsExact identifier
application number: M013
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATETarget Corporationbc65e205-64fd-4764-8c5e-2793af4e9adf2026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLCa7e27000-a26b-46c2-823e-663f4e76db742026-05-11WarningsExact identifier
application number: M013
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNadd6952e-9dd5-487c-93e6-337e9d6a487246
198440acetaminophen 500 MG Oral TabletSCDadd6952e-9dd5-487c-93e6-337e9d6a487246
198440APAP 500 MG Oral TabletSYadd6952e-9dd5-487c-93e6-337e9d6a487246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-980-62378080980621 BOTTLE in 1 CARTON (37808-980-62) / 24 TABLET in 1 BOTTLE1 bottle1991-06-150000-00-00NoNoCurrent