Home NDC 55758-026 Dolex
Product NDC 55758-026
11-digit product format 557580026
Labeler code 55758
Product ID 55758-026_12dcac76-11bc-2c3b-e063-6394a90a35c6
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form SUSPENSION
Route ORAL
Labeler Pharmadel LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-01
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 Dolex
Brand name suffix Children 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 55758-026-04 DolexChildren Pain and Fever 1 in 1 BOX SUSPENSION 1 3 55758-026-04 DolexChildren 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 55758-026 DOLEX CHILDREN PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [PHARMADEL LLC] 3 Current NDC, 2 package rows 20240307_f9158463-aeb1-5de0-e053-6294a90a748b.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 · 1,576 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55758-026-04 55758002604 1 BOTTLE in 1 BOX (55758-026-04) / 118 mL in 1 BOTTLE 1 bottle 2023-01-01 No No Current