Home NDC 53499-6864 Cough Relief
Product NDC 53499-6864
11-digit product format 534996864
Labeler code 53499
Product ID 53499-6864_a7c5f6a5-ce84-467a-aca0-866d1373a9a9
Type HUMAN OTC DRUG
Nonproprietary name Cough Relief
Dosage form SYRUP
Route ORAL
Labeler Schwabe North America, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2024-01-19
Substance PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; TIN; SPONGIA OFFICINALIS SKELETON, ROASTED
Active strength 1; 3; 3; 6; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_C]/120mL; [hp_X]/120mL
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 Cough Relief
Brand name suffix ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL ACONITUM NAPELLUS 3 [hp_X]/120mL BRYONIA ALBA ROOT 3 [hp_X]/120mL CALCIUM SULFIDE 6 [hp_C]/120mL TIN 6 [hp_C]/120mL SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X]/120mL
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53499-6864-4 Cough ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT 120 mL in 1 BOTTLE SYRUP 120 4 53499-6864-4 Cough ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT 1 in 1 BOX SYRUP 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-6864 COUGH RELIEF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT (COUGH RELIEF) SYRUP [SCHWABE NORTH AMERICA, INC.] 2 Current NDC, 2 package rows 20250321_a95610e3-774b-4745-a2a4-fc3ba51ab4c5.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53499-6864-4 53499686404 1 BOTTLE in 1 BOX (53499-6864-4) / 120 mL in 1 BOTTLE 1 bottle 2024-01-19 No No Current