FDA.reportPublic FDA data

Pain and Fever

Product NDC
49580-0282
11-digit product format
495800282
Labeler code
49580
Product ID
49580-0282_d2a041fc-599a-48bb-8582-045c61473752
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
P & L Development, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-31
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
Pain and Fever
Brand name suffix
Childrens
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
49580-0282-2Pain and FeverChildrens118 mL in 1 BOTTLE, PLASTICSUSPENSION1187
49580-0282-4Pain and FeverChildrens118 mL in 1 BOTTLE, PLASTICSUSPENSION1187
49580-0282-4Pain and FeverChildrens1 in 1 BOXSUSPENSION17
49580-0282-8Pain and FeverChildrens1 in 1 BOXSUSPENSION17
49580-0282-8Pain and FeverChildrens237 mL in 1 BOTTLE, PLASTICSUSPENSION2377

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0282PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC]6Current NDC, Legacy NDC, 5 package rows20240217_b815fcae-8bba-4737-ac10-29a32fb69275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNb815fcae-8bba-4737-ac10-29a32fb692757
307668acetaminophen 32 MG/ML Oral SuspensionSCDb815fcae-8bba-4737-ac10-29a32fb692757
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYb815fcae-8bba-4737-ac10-29a32fb692757
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYb815fcae-8bba-4737-ac10-29a32fb692757
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYb815fcae-8bba-4737-ac10-29a32fb692757
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYb815fcae-8bba-4737-ac10-29a32fb692757
307668APAP 32 MG/ML Oral SuspensionSYb815fcae-8bba-4737-ac10-29a32fb692757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0282-249580028202118 mL in 1 BOTTLE, PLASTIC (49580-0282-2) 118 ml2016-05-310000-00-00NoNoCurrent
49580-0282-4495800282041 BOTTLE, PLASTIC in 1 BOX (49580-0282-4) / 118 mL in 1 BOTTLE, PLASTIC2016-05-310000-00-00NoNoCurrent
49580-0282-8495800282081 BOTTLE, PLASTIC in 1 BOX (49580-0282-8) / 237 mL in 1 BOTTLE, PLASTIC2016-05-310000-00-00NoNoCurrent