FDA.reportPublic FDA data

Acetaminophen

Product NDC
68094-330
11-digit product format
680940330
Labeler code
68094
Product ID
68094-330_969e07e8-8e42-47bc-a77b-0ff7893d3175
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-15
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
Acetaminophen
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
68094-330-59Acetaminophen10.15 mL in 1 CUP, UNIT-DOSESUSPENSION10.1514
68094-330-61Acetaminophen10 in 1 TRAYSUSPENSION1014
68094-330-61Acetaminophen10 in 1 CASESUSPENSION1014
68094-330-62Acetaminophen3 in 1 CASESUSPENSION314
68094-330-62Acetaminophen10 in 1 TRAYSUSPENSION1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-330ACETAMINOPHEN SUSPENSION [PRECISION DOSE, INC.]12Current NDC, Legacy NDC, 5 package rows20250224_e1d4f562-433c-4344-9b77-1a7c731d1be5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 32 MG/ML Oral SuspensionSCDe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668APAP 32 MG/ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-330-596809403305910.15 mL in 1 CUP, UNIT-DOSE10.15 mlHistorical
68094-330-616809403306110 TRAY in 1 CASE (68094-330-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE (68094-330-59) 10 tray2020-01-150000-00-00NoNoCurrent
68094-330-62680940330623 TRAY in 1 CASE (68094-330-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE (68094-330-59) 3 tray2020-01-150000-00-00NoNoCurrent