Home NDC 76281-526 Childrens Pain and Fever
Product NDC 76281-526
11-digit product format 762810526
Labeler code 76281
Product ID 76281-526_5b15b381-438f-403f-8db3-ac8576244ea0
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form SUSPENSION
Route ORAL
Labeler AptaPharma Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-08-21
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 Childrens Pain and 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 76281-526-23 Childrens Pain and Fever 59 mL in 1 BOTTLE SUSPENSION 59 3 76281-526-23 Childrens Pain and Fever 1 in 1 CARTON SUSPENSION 1 3 76281-526-24 Childrens Pain and Fever 1 in 1 CARTON SUSPENSION 1 3 76281-526-24 Childrens Pain and Fever 118 mL in 1 BOTTLE SUSPENSION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76281-526 CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [APTAPHARMA INC.] 3 Current NDC, Legacy NDC, 4 package rows 20240203_9064943f-836f-4853-b6f2-2c4879941eeb.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 78 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 76281-526-23 76281052623 1 BOTTLE in 1 CARTON (76281-526-23) / 59 mL in 1 BOTTLE 1 bottle 2024-01-30 No No Current 76281-526-24 76281052624 1 BOTTLE in 1 CARTON (76281-526-24) / 118 mL in 1 BOTTLE 1 bottle 2020-09-30 0000-00-00 No No Current