Home NDC 53499-4194 Allergy and Sinus Relief
Product NDC 53499-4194
11-digit product format 534994194
Labeler code 53499
Product ID 53499-4194_229f5cd4-f462-475f-819c-68883e543b16
Type HUMAN OTC DRUG
Nonproprietary name PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Schwabe North American, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2024-08-01
Substance PELARGONIUM SIDOIDES ROOT; HYDRASTIS CANADENSIS WHOLE; POTASSIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; PULSATILLA VULGARIS; SILICON DIOXIDE
Active strength 1; 6; 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
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 Allergy and Sinus Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1 HYDRASTIS CANADENSIS WHOLE 6 [hp_X]/1 POTASSIUM CHLORIDE 3 [hp_X]/1 SANGUINARIA CANADENSIS ROOT 6 [hp_X]/1 PULSATILLA VULGARIS 6 [hp_X]/1 SILICON DIOXIDE 6 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53499-4194-2 Allergy and Sinus Relief 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 2 53499-4194-2 Allergy and Sinus Relief 2 in 1 CARTON TABLET, CHEWABLE 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-4194 ALLERGY AND SINUS RELIEF (PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE) TABLET, CHEWABLE [SCHWABE NORTH AMERICAN, INC.] 1 Current NDC, 2 package rows 20240802_c90cc6f5-14ec-41a3-a20a-4e8018bb02fb.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Allergy and Sinus Relief PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE Schwabe North American, Inc. c90cc6f5-14ec-41a3-a20a-4e8018bb02fb 2025-08-25 Warnings Exact identifier ndc (product): 53499-4194
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53499-4194-2 53499419402 2 BLISTER PACK in 1 CARTON (53499-4194-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2024-08-01 No No Current