Home NDC 68391-288 Childrens Pain Reliever
Product NDC 68391-288
11-digit product format 683910288
Labeler code 68391
Product ID 68391-288_d65d6677-36da-421d-bb29-0791a28681ac
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler BJWC (Berkley & Jensen / BJ's)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-30
Marketing end 2027-01-29
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
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 Pain Reliever 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 68391-288-12 Childrens Pain Reliever 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 4 68391-288-12 Childrens Pain Reliever 3 in 1 BOX SUSPENSION 3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-288 CHILDRENS PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [BJWC (BERKLEY & JENSEN / BJ'S)] 3 Current NDC, Legacy NDC, 2 package rows 20240224_851228ea-eaf3-452b-a9ce-8cd244a0eaf3.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 68 of 79 · 1,579 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 68391-288-12 68391028812 3 BOTTLE, PLASTIC in 1 BOX (68391-288-12) / 118 mL in 1 BOTTLE, PLASTIC 2019-08-30 2027-01-29 No No Current