Home NDC 53499-1693 Nightime Cough and Bronchial
Product NDC 53499-1693
11-digit product format 534991693
Labeler code 53499
Product ID 53499-1693_b1e89f9d-53fc-4469-b950-a341e3b43463
Type HUMAN OTC DRUG
Nonproprietary name ACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN
Dosage form SYRUP
Route ORAL
Labeler Schwabe North America
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-03-03
Substance ACONITUM NAPELLUS; ARABICA COFFEE BEAN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; MEDICAGO SATIVA LEAF; OAT; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN
Active strength 3; 6; 3; 6; 1; 1; 3; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL
Pharmacologic classes Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Nightime 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 MEDICAGO SATIVA LEAF 1 [hp_X]/120mL OAT 1 [hp_X]/120mL ARABICA COFFEE BEAN 6 [hp_X]/120mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 8 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 53499-1693-5 Nightime Cough and Bronchial 1 in 1 CARTON SYRUP 1 4 53499-1693-5 Nightime Cough and Bronchial 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 4 53499-1693-9 Nightime Cough and Bronchial 1 in 1 CARTON SYRUP 1 4 53499-1693-9 Nightime Cough and Bronchial 240 mL in 1 BOTTLE, PLASTIC SYRUP 240 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53499-1693 NIGHTIME COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [SCHWABE NORTH AMERICA] 2 Current NDC, 4 package rows 20241006_b3899e48-2db8-4deb-b976-eb143b6223dd.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 Nightime Cough and Bronchial ACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN Schwabe North America b3899e48-2db8-4deb-b976-eb143b6223dd 2025-12-04 Warnings Exact identifier ndc (product): 53499-1693
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 53499-1693-5 53499169305 1 BOTTLE, PLASTIC in 1 CARTON (53499-1693-5) / 120 mL in 1 BOTTLE, PLASTIC 2023-03-03 No No Current 53499-1693-9 53499169309 1 BOTTLE, PLASTIC in 1 CARTON (53499-1693-9) / 240 mL in 1 BOTTLE, PLASTIC 2023-03-03 No No Current