FDA.reportPublic FDA data

Childrens Pain and Fever

Product NDC
59779-308
11-digit product format
597790308
Labeler code
59779
Product ID
59779-308_04b3c603-52c8-45ee-9aa5-c1d92a327ff9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS Pharmacy
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-28
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 and Fever
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
59779-308-26Childrens Pain and Fever1 in 1 CARTONSUSPENSION19
59779-308-26Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1189
59779-308-34Childrens Pain and Fever2 in 1 CARTONSUSPENSION29
59779-308-34Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-308CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]8Current NDC, Legacy NDC, 4 package rows20240902_d6c8118c-bf78-4194-9b14-8de33c3ecdb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNd6c8118c-bf78-4194-9b14-8de33c3ecdb79
307668acetaminophen 32 MG/ML Oral SuspensionSCDd6c8118c-bf78-4194-9b14-8de33c3ecdb79
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYd6c8118c-bf78-4194-9b14-8de33c3ecdb79
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYd6c8118c-bf78-4194-9b14-8de33c3ecdb79
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYd6c8118c-bf78-4194-9b14-8de33c3ecdb79
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYd6c8118c-bf78-4194-9b14-8de33c3ecdb79
307668APAP 32 MG/ML Oral SuspensionSYd6c8118c-bf78-4194-9b14-8de33c3ecdb79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-308-26597790308261 BOTTLE in 1 CARTON (59779-308-26) / 118 mL in 1 BOTTLE1 bottle2014-02-280000-00-00NoNoCurrent
59779-308-34597790308342 BOTTLE in 1 CARTON (59779-308-34) > 118 mL in 1 BOTTLE2 bottle2014-02-280000-00-00NoNoCurrent