FDA.reportPublic FDA data

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

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 Acetaminophen
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
68e214cd-2d09-42d0-a4e9-b1b81af6be3cAvailable on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.68e214cd-2d09-42d0-a4e9-b1b81af6be3c2026-03-26WarningsExact identifier
ndc (product): 68788-8397

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 bottle2023-03-01NoNoCurrent