Home NDC 68163-695 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 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 ADWE Childrens Pain Fever
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68163-695-04 ADWE Childrens Pain Fever 120 mL in 1 BOTTLE, PLASTIC SUSPENSION 120 5 68163-695-04 ADWE Childrens Pain Fever 1 in 1 PACKAGE SUSPENSION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-695 ADWE CHILDRENS PAIN FEVER (ACETAMINOPHEN) SUSPENSION [RARITAN PHARMACEUTICALS INC] 4 Current NDC, Legacy NDC, 2 package rows 20240719_79a3232f-0211-4c8a-acee-4f87e06ffc26.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 84 · 1,663 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68163-695-04 68163069504 1 BOTTLE, PLASTIC in 1 PACKAGE (68163-695-04) / 120 mL in 1 BOTTLE, PLASTIC 2022-01-17 0000-00-00 No No Current