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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668

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

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 bottle2024-03-28NoNoHistorical