sinulief

Generic: loratadine

Labeler: rosewell pharmaceuticals llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sinulief
Generic Name loratadine
Labeler rosewell pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
RoseWell Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 85510-101
Product ID 85510-101_4084b4ad-91cf-9487-e063-6394a90a3cbe
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-04-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85510101
Hyphenated Format 85510-101

Supplemental Identifiers

RxCUI
311372
UNII
7AJO3BO7QN

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sinulief (source: ndc)
Generic Name loratadine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BLISTER PACK (85510-101-01)
source: ndc

Packages (1)

85510-101-01 10 TABLET in 1 BLISTER PACK (85510-101-01)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

SinuLief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4084b4ad-91cf-9487-e063-6394a90a3cbe", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["32619143-a782-3497-e063-6394a90aaaec"], "manufacturer_name": ["RoseWell Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BLISTER PACK (85510-101-01)", "package_ndc": "85510-101-01", "marketing_start_date": "20250418"}], "brand_name": "SinuLief", "product_id": "85510-101_4084b4ad-91cf-9487-e063-6394a90a3cbe", "dosage_form": "TABLET", "product_ndc": "85510-101", "generic_name": "Loratadine", "labeler_name": "RoseWell Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SinuLief", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250418", "listing_expiration_date": "20261231"}