ADWE Childrens Pain Fever

Product NDC
68163-695
11-digit product format
681630695
Labeler code
68163
Product ID
68163-695_3a1d9104-d156-2b4e-e063-6394a90a8d05
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
RARITAN PHARMACEUTICALS INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-17
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
ADWE Childrens Pain Fever
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
68163-695-04ADWE Childrens Pain Fever120 mL in 1 BOTTLE, PLASTICSUSPENSION1205
68163-695-04ADWE Childrens Pain Fever1 in 1 PACKAGESUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-695ADWE CHILDRENS PAIN FEVER (ACETAMINOPHEN) SUSPENSION [RARITAN PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 2 package rows20240719_79a3232f-0211-4c8a-acee-4f87e06ffc26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 32 MG/ML Oral SuspensionSCD79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265
307668APAP 32 MG/ML Oral SuspensionSY79a3232f-0211-4c8a-acee-4f87e06ffc265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68163-695-04681630695041 BOTTLE, PLASTIC in 1 PACKAGE (68163-695-04) / 120 mL in 1 BOTTLE, PLASTIC2022-01-170000-00-00NoNoCurrent