FDA.reportPublic FDA data

Pain and Fever

Product NDC
37808-161
11-digit product format
378080161
Labeler code
37808
Product ID
37808-161_c5a7015a-d2a0-446b-9ea1-330bee7ffd6b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
H E B
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-15
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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 and Fever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

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
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86a072a9-c3b8-47f7-8598-d66e3d30e762Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-161-16Pain and Fever1 in 1 CARTONSUSPENSION15
37808-161-16Pain and Fever59 mL in 1 BOTTLESUSPENSION595

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
SORBITOLINACTIVE INGREDIENT506T60A25RPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3
WATERINACTIVE INGREDIENT059QF0KO0RPAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-161PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [H E B]5Current NDC, Legacy NDC, 2 package rows20240828_86a072a9-c3b8-47f7-8598-d66e3d30e762.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 14 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENHHH Pharmaceuticals0c66b05d-132d-4c79-abfe-415fd68bbb9c2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINBetter Living Brands, LLC5ebd04d8-52c7-4c72-a4c1-fc7fd488ea242026-05-06WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leader519eb216-9fa6-4d60-a2a4-3310bdb5b4ab2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINGeiss, Destin & Dunn Inc.b8f6e486-5332-4c46-ab6c-7de04c91c60b2026-05-06WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.c60494f0-5a50-41da-bcb4-88178ded54b72026-05-05WarningsExact identifier
application number: M013
equate pain relief pmACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.85129749-c1a7-4c4a-933f-c3c4768e2cdd2026-05-05WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEf3feca65-adc1-469f-bef6-12c860599abe2026-05-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENStrategic Sourcing Services LLC4dda3534-4e83-447b-be75-33dadce06c472026-05-04WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINMajor Pharmaceuticals4ba6eed3-004a-4576-b7f7-685fae49cf6a2026-05-04WarningsExact identifier
application number: M013
Back and BodyASPIRIN, CAFFEINEKroger Company366b58db-1ac3-427b-b42a-5f56a14e298c2026-05-01WarningsExact identifier
application number: M013
Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8ed9a9f0-d37e-5c10-e053-2a95a90a559f2026-05-01WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENSavings Distributors LLC8ed90757-833e-f4d9-e053-2995a90a29db2026-05-01WarningsExact identifier
application number: M013
Acetaminophen , Aspirin and CaffeineACETAMINOPHEN , ASPIRIN AND CAFFEINESoftgel Healthcare Pvt Ltd4543e156-1deb-666e-e063-6394a90a719c2026-04-27WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd45478958-ad86-4d87-e063-6394a90a3c452026-04-27WarningsExact identifier
application number: M013
Medique at Home AspirinASPIRINSportpharm LLC0f2aa75e-534f-478b-811e-fb492b7af9bb2026-04-24WarningsExact identifier
application number: M013
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGSportpharm LLCcc280926-ad94-4017-a04a-b4315807eacb2026-04-24WarningsExact identifier
application number: M013
AspirinASPIRINHealth Pharma USA LLC503868bb-48e0-b718-e063-6394a90a9c5b2026-04-24WarningsExact identifier
application number: M013
BC CHERRYASPIRIN AND CAFFEINEMedtech Products Inc.c5fa6660-a549-49ff-ac2b-5799afa22ec52026-04-24WarningsExact identifier
application number: M013
Doans Maximum StrengthMAGNESIUM SALICYLATEDr. Reddy's Laboratories Inc.c906df41-bb45-03ea-b1a8-2b9816d55c972026-04-24WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.48912649-9fa1-a11f-e063-6294a90a8a722026-04-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN86a072a9-c3b8-47f7-8598-d66e3d30e7625
307668acetaminophen 32 MG/ML Oral SuspensionSCD86a072a9-c3b8-47f7-8598-d66e3d30e7625
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY86a072a9-c3b8-47f7-8598-d66e3d30e7625
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY86a072a9-c3b8-47f7-8598-d66e3d30e7625
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY86a072a9-c3b8-47f7-8598-d66e3d30e7625
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY86a072a9-c3b8-47f7-8598-d66e3d30e7625
307668APAP 32 MG/ML Oral SuspensionSY86a072a9-c3b8-47f7-8598-d66e3d30e7625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-161-16378080161161 BOTTLE in 1 CARTON (37808-161-16) / 59 mL in 1 BOTTLE1 bottle2011-12-150000-00-00NoNoCurrent