FDA.reportPublic FDA data

Pain Relief

Product NDC
37808-195
11-digit product format
378080195
Labeler code
37808
Product ID
37808-195_eef88a02-d62d-47e1-85f1-16d3d20e86d1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
H E B
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-10
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

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
99699cd6-ba7d-4db0-9f0f-0f2c1a369138Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-195-08Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED2418
37808-195-08Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED118
37808-195-12Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED118
37808-195-12Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10018
37808-195-20Pain ReliefExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22518

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [H E B]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-195PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [H E B]17Current NDC, Legacy NDC, 5 package rows20250406_99699cd6-ba7d-4db0-9f0f-0f2c1a369138.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 51 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediacare Childrens Acetaminophen GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH596372c7-eca3-4527-8e22-ab0751e2526b2024-12-30WarningsExact identifier
application number: M013
Bayer Genuine AspirinBAYER GENUINE ASPIRINLil' Drug Store Products, Inc.d17834d7-cb3e-6bf2-e053-2a95a90ae5c12024-12-30WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fd2b46-683e-4cf5-e053-2995a90a55122024-12-30WarningsExact identifier
application number: M013
Night Time Severe Cold and Cough ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLChain Drug Consortium, LLCc8e9b57b-83e9-46c5-9791-02c4c2b940042024-12-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
application number: M013
AspirinASPIRINAdvance Pharmaceutical Inc.f6a9ea44-08b8-4a33-bfbd-68cb2d852c392024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCcfc7eac3-35be-4002-b8ef-be1dfc8caf692024-12-26WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCa3031139-4709-43f2-95a8-89840c595f7f2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGWALGREENS CO.98bb28ed-d146-ca3d-e053-2a95a90a9eaf2024-12-26WarningsExact identifier
application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mgACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MGWALGREENS CO.982faa74-d498-cd1e-e053-2995a90afa1e2024-12-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.11bf6e1b-aed9-4f8f-9f03-ea911ae9f7022024-12-23WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENRUGBY LABORATORIES295b0d00-4d4a-405f-9325-d01c5d4f3ed42024-12-20WarningsExact identifier
application number: M013
Walgreens Pain Relief PowderASPIRIN AND CAFFEINEWalgreens Co.61493d34-2432-4683-9b32-e1851a4337be2024-12-18WarningsExact identifier
application number: M013
Reese Headache PowdersASPIRIN AND CAFFEINEReese Pharmaceutical Co386f7a6c-4bfc-4140-a67b-07f6b520d58f2024-12-18WarningsExact identifier
application number: M013
NobleAid PAIN RELIEVERASPIRINNoble Otc LLCaa08e488-2f69-4d7e-86ba-ccfad563edcf2024-12-18WarningsExact identifier
application number: M013
Dollar General Headache PowdersASPIRIN AND CAFFEINEDolgencorp, LLC11b0271b-d65c-49c4-a081-d71044a0e04c2024-12-18WarningsExact identifier
application number: M013
Family Wellness Pain Relief PowderASPIRIN AND CAFFEINEFamily Dollar Services Incb2e55de7-3c36-49cc-8f7f-1013fd1ec3592024-12-18WarningsExact identifier
application number: M013
Best Choice Pain Relief PowderASPIRIN AND CAFFEINEValue Mercha95b9b22-ea5c-4a02-b35d-c8ae1e1176042024-12-18WarningsExact identifier
application number: M013
Walmart Pain Relief PowderASPIRIN AND CAFFEINEWalmartc69aa61f-6a74-40a3-8737-195fa545e2612024-12-18WarningsExact identifier
application number: M013
Quality Choice Pain Relief PowderASPIRIN AND CAFFEINEChain Drug Marketing Association8e1f4057-4968-4523-9b3f-55aea421b6742024-12-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN99699cd6-ba7d-4db0-9f0f-0f2c1a36913818
198440acetaminophen 500 MG Oral TabletSCD99699cd6-ba7d-4db0-9f0f-0f2c1a36913818
198440APAP 500 MG Oral TabletSY99699cd6-ba7d-4db0-9f0f-0f2c1a36913818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-195-08378080195081 BOTTLE, PLASTIC in 1 CARTON (37808-195-08) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
37808-195-12378080195121 BOTTLE, PLASTIC in 1 CARTON (37808-195-12) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2004-05-100000-00-00NoNoCurrent
37808-195-2037808019520225 TABLET, COATED in 1 BOTTLE, PLASTIC (37808-195-20) 2004-05-100000-00-00NoNoCurrent