Childrens Acetaminophen

Product NDC
68788-8397
11-digit product format
687888397
Labeler code
68788
Product ID
68788-8397_2e3ab892-4501-4a95-8e3d-4ec4e475835d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
343
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-01
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Acetaminophen
Listing expiration
2027-12-31

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
68788-8397-1Childrens Acetaminophen118 mL in 1 BOTTLESUSPENSION1184
68788-8397-1Childrens Acetaminophen1 in 1 CARTONSUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8397-1ML - Milliliter68788-83977a79e38e-21ba-4af7-b5ed-1184b27609bc12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8397CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250228_68e214cd-2d09-42d0-a4e9-b1b81af6be3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 32 MG/ML Oral SuspensionSCD68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4
307668APAP 32 MG/ML Oral SuspensionSY68e214cd-2d09-42d0-a4e9-b1b81af6be3c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8397-1687888397011 BOTTLE in 1 CARTON (68788-8397-1) / 118 mL in 1 BOTTLE1 bottle2023-03-01NoNoHistorical