FDA.reportPublic FDA data

Childrens Pain Relief and Fever Reducer Oral Suspension Cherry

Product NDC
83474-001
11-digit product format
834740001
Labeler code
83474
Product ID
83474-001_46f2d5ac-91bc-922f-e063-6394a90af4ed
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Puro Pharma Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-28
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry
Listing expiration
2027-12-31

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
a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83474-001-04Childrens Pain Relief and Fever Reducer Oral Suspension Cherry1 in 1 CARTONSUSPENSION13
83474-001-04Childrens Pain Relief and Fever Reducer Oral Suspension Cherry118 mL in 1 BOTTLESUSPENSION1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83474-001-04ML - Milliliter83474-001a0e92883-23a7-4f7e-9bfb-3170eba185a312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83474-001CHILDRENS PAIN RELIEF AND FEVER REDUCER ORAL SUSPENSION CHERRY (ACETAMINOPHEN) SUSPENSION [PURO PHARMA INC.]2Current NDC, 2 package rows20240410_a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009.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 44 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ACETAMINOPHENCHILDRENS ACETAMINOPHEN ORALAARNA USA INC.38070d15-2678-4e59-e063-6294a90ab6902025-06-20WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENMorning Star OTC8502ea21-937d-4b33-a3e0-ffab5dc38cd82025-06-19WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
application number: M013
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact identifier
application number: M013
Aspirina CafeinaASPIRIN,CAFFEINEBayer HealthCare LLC.2e709acc-325a-baca-e063-6394a90a24be2025-06-12WarningsExact identifier
application number: M013
AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.696f55b1-536c-40c4-91f7-b572c39220db2025-06-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.6dea9e11-ff99-63c7-e053-2a91aa0a5b542025-06-10WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC372be427-acbd-c10c-e063-6294a90a572d2025-06-09WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacyd6c8118c-bf78-4194-9b14-8de33c3ecdb72025-06-06WarningsExact identifier
application number: M013
Dolo-NeuroBionACETAMINOPHENBENARD INDUSTRIES INCb8310770-84d1-4a6f-8e23-9974947f92f12025-06-04WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATERite Aid Corporation69bda7d7-8660-4e8d-b8ac-892a3b1f21242025-06-03WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENKinderFarms, LLCfb74e8f9-d72f-4681-90bd-df48364405b52025-06-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENP & L Development, LLCb815fcae-8bba-4737-ac10-29a32fb692752025-05-30WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKinderFarms, LLC81cc4900-226b-4c49-ba9c-5747d2a501b12025-05-29WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBryant Ranch Prepacke08a7ab1-4b68-422a-97bd-2c53266339432025-05-29WarningsExact identifier
application number: M013
Acetaminophen GelcapsACETAMINOPHENKroger30d3f2d0-da35-7f6f-e063-6294a90a9c222025-05-23WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.fcffa7e6-145c-6bc0-e053-6294a90a47512025-05-23WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1c083e29-8732-4ecd-ab4b-9038acbd0b9d2025-05-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNa2afaee7-19f3-4a42-a5b8-1d0ef3ecf0093
307668acetaminophen 32 MG/ML Oral SuspensionSCDa2afaee7-19f3-4a42-a5b8-1d0ef3ecf0093
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYa2afaee7-19f3-4a42-a5b8-1d0ef3ecf0093
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYa2afaee7-19f3-4a42-a5b8-1d0ef3ecf0093
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYa2afaee7-19f3-4a42-a5b8-1d0ef3ecf0093
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYa2afaee7-19f3-4a42-a5b8-1d0ef3ecf0093
307668APAP 32 MG/ML Oral SuspensionSYa2afaee7-19f3-4a42-a5b8-1d0ef3ecf0093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83474-001-04834740001041 BOTTLE in 1 CARTON (83474-001-04) / 118 mL in 1 BOTTLE1 bottle2024-03-28NoNoCurrent