Home NDC 53499-1293 Cough and Bronchial
Product NDC 53499-1293
11-digit product format 534991293
Labeler code 53499
Product ID 53499-1293_80822178-1a72-4645-9365-b122333be561
Type HUMAN OTC DRUG
Nonproprietary name ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN
Dosage form SYRUP
Route ORAL
Labeler Schwabe North America
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-02-08
Substance ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN
Active strength 3; 3; 6; 3; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_X]/120mL; [hp_C]/120mL
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 Cough and Bronchial
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACONITUM NAPELLUS 3 [hp_X]/120mL BRYONIA ALBA ROOT 3 [hp_X]/120mL CALCIUM SULFIDE 6 [hp_C]/120mL SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X]/120mL TIN 6 [hp_C]/120mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 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 53499-1293-5 Cough and Bronchial 1 in 1 CARTON SYRUP 1 4 53499-1293-5 Cough and Bronchial 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 4 53499-1293-9 Cough and Bronchial 240 mL in 1 BOTTLE, PLASTIC SYRUP 240 4 53499-1293-9 Cough and Bronchial 1 in 1 CARTON SYRUP 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-1293 COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [SCHWABE NORTH AMERICA] 3 Current NDC, 4 package rows 20241009_791a8da1-0de3-4798-bbc9-b3538ea28dd7.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 Cough and Bronchial ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN Schwabe North America 791a8da1-0de3-4798-bbc9-b3538ea28dd7 2025-12-08 Warnings Exact identifier ndc (product): 53499-1293
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 53499-1293-5 53499129305 1 BOTTLE, PLASTIC in 1 CARTON (53499-1293-5) / 120 mL in 1 BOTTLE, PLASTIC 2023-02-08 No No Current 53499-1293-9 53499129309 1 BOTTLE, PLASTIC in 1 CARTON (53499-1293-9) / 240 mL in 1 BOTTLE, PLASTIC 2023-02-08 No No Current