Home NDC 85510-101-01 SinuLief
Product NDC 85510-101
Requested package NDC 85510-101-01
11-digit product format 855100101
Labeler code 85510
Product ID 85510-101_4084b4ad-91cf-9487-e063-6394a90a3cbe
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler RoseWell Pharmaceuticals LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-18
Substance LORATADINE
Active strength 10 mg/1
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 SinuLief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AJO3BO7QN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311372 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 85510-101-01 SinuLief 10 in 1 BLISTER PACK TABLET 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85510-101 SINULIEF (LORATADINE) TABLET [ROSEWELL PHARMACEUTICALS LLC] 1 Current NDC, 1 package rows 20250424_32619143-a782-3497-e063-6394a90aaaec.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 123 of 180 · 3,583 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 85510-101-01 85510010101 10 TABLET in 1 BLISTER PACK (85510-101-01) 10 tablet 2025-04-18 No No Current