Home NDC 52412-901 Pediacare Childrens Grape
Product NDC 52412-901
11-digit product format 524120901
Labeler code 52412
Product ID 52412-901_2a810efe-646a-f310-e063-6394a90ab074
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-03
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Pediacare Childrens Grape
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 52412-901-04 Pediacare Childrens Grape 118 mL in 1 BOTTLE SUSPENSION 118 2 52412-901-04 Pediacare Childrens Grape 1 in 1 CARTON SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52412-901 PEDIACARE CHILDRENS GRAPE (ACETAMINOPHEN) SUSPENSION [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH] 2 Current NDC, Legacy NDC, 2 package rows 20250101_f9d531a2-234c-4feb-8f05-212dbee83dfe.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 39 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52412-901-04 52412090104 1 BOTTLE in 1 CARTON (52412-901-04) / 118 mL in 1 BOTTLE 1 bottle 2023-01-03 0000-00-00 No No Current