Home NDC 81522-285 Childrens Acetaminophen
Product NDC 81522-285
11-digit product format 815220285
Labeler code 81522
Product ID 81522-285_0f5eba37-e7e8-4e43-9633-fbc0f8bce709
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler FSA Store Inc. (Caring Mills)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-18
Marketing end 2027-03-28
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 Acetaminophen
Brand name suffix Dye Free Grape Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81522-285-04 Childrens AcetaminophenDye Free Grape 1 in 1 CARTON SUSPENSION 1 2 81522-285-04 Childrens AcetaminophenDye Free Grape 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-285 CHILDRENS ACETAMINOPHEN DYE FREE GRAPE (ACETAMINOPHEN) SUSPENSION [FSA STORE INC. (CARING MILLS)] 2 Current NDC, Legacy NDC, 2 package rows 20240206_58dd57f1-6508-4635-b508-870218421c48.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 63 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 81522-285-04 81522028504 1 BOTTLE, PLASTIC in 1 CARTON (81522-285-04) / 118 mL in 1 BOTTLE, PLASTIC 2022-04-18 2027-03-28 No No Current