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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
application number: M013
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
application number: M013
Pain Reliever, Caseys 4goodACETAMINOPHEN 500 MG, TABLETLil' Drug Store Products, Inc.039d2cf1-57f6-4d9d-e063-6394a90a54922024-12-16WarningsExact identifier
application number: M013
Extra Strength Headache, Caseys 4goodACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0425c6a8-a3ea-24ad-e063-6294a90ae15a2024-12-16WarningsExact identifier
application number: M013
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e75551-1e50-9896-e053-2a95a90aafd42024-12-14WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e5df0e-06d3-6f72-e053-2995a90a2d072024-12-14WarningsExact identifier
application number: M013
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLCb8ee568c-80cf-4e35-865e-35516bdab0fd2024-12-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.c0de0bd2-4868-46dc-a20f-3ca02caaa26b2024-12-11WarningsExact identifier
application number: M013
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
application number: M013
EXTRA STRENGTH Headache Relief geltabsACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.b432771a-4f7d-4d39-a038-d1561d8f67082024-12-11WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)223ffb2b-3ee5-4118-955b-bc4fa4e8a2e62024-12-10WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUNFIe689c9e3-dd4d-c646-e053-2a95a90a4b6a2024-12-09WarningsExact identifier
application number: M013
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART972f09a7-2aa1-4b1b-a6dc-2c4578a078032024-12-05WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6feff0a-3347-194d-e053-2a95a90acd202024-12-05WarningsExact 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