Dye Free Childrens Acetaminophen

Product NDC
68094-061
11-digit product format
680940061
Labeler code
68094
Product ID
68094-061_046ba40e-c1d0-4bdf-b8c9-fc46c1a6ed19
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
2022-08-02
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
Dye Free Childrens 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
68094-061-59Dye Free Childrens Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION54
68094-061-61Dye Free Childrens Acetaminophen10 in 1 TRAYSUSPENSION104
68094-061-61Dye Free Childrens Acetaminophen10 in 1 CASESUSPENSION104
68094-061-62Dye Free Childrens Acetaminophen3 in 1 CASESUSPENSION34
68094-061-62Dye Free Childrens Acetaminophen10 in 1 TRAYSUSPENSION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-061-59ML - Milliliter68094-0617ffde884-046e-4467-bf19-e6963019ceeb12022-09-12
68094-061-61ML - Milliliter68094-06101f444ad-976b-4dee-a6d8-58370a3ce67612022-09-12
68094-061-62ML - Milliliter68094-06196850414-3946-419e-af60-8205fe94744c12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-061DYE FREE CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]4Current NDC, Legacy NDC, 5 package rows20250122_5cc698fa-0841-4851-ae21-0aac8b40eb0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 32 MG/ML Oral SuspensionSCD5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668APAP 32 MG/ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-061-59680940061595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-061-616809400616110 TRAY in 1 CASE (68094-061-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-061-59) 10 tray2022-08-020000-00-00NoNoCurrent
68094-061-62680940061623 TRAY in 1 CASE (68094-061-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-061-59) 3 tray2022-08-020000-00-00NoNoCurrent