Home NDC 53113-516 DR. SANA PAIN AND FEVER FOR Children
Product NDC 53113-516
11-digit product format 531130516
Labeler code 53113
Product ID 53113-516_d3ebeaac-ec26-4f27-be5d-739918117f2f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SYRUP
Route ORAL
Labeler GADAL Laboratories, Inc
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-14
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2026-12-31
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 DR. SANA PAIN AND FEVER FOR Children
Listing expiration 2026-12-31 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 307675 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 53113-516-06 DR. SANA PAIN AND FEVER FOR Children 1 in 1 BOX SYRUP 1 2 53113-516-06 DR. SANA PAIN AND FEVER FOR Children 180 mL in 1 BOTTLE SYRUP 180 2
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 76 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 Sample Exclude flag Status 53113-516-06 53113051606 1 BOTTLE in 1 BOX (53113-516-06) / 180 mL in 1 BOTTLE 1 bottle 2025-04-14 No No Current