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
IngredientStrength
ACONITUM NAPELLUS3 [hp_X]/120mL
ARABICA COFFEE BEAN6 [hp_X]/120mL
BRYONIA ALBA ROOT3 [hp_X]/120mL
CALCIUM SULFIDE6 [hp_C]/120mL
MEDICAGO SATIVA LEAF1 [hp_X]/120mL
OAT1 [hp_X]/120mL
SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]/120mL
TIN6 [hp_C]/120mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 3SW678MX72, T7J046YI2B, 1MBW07J51Q, HY3L927V6M, Z6J799EAJK, 1PIP394IID, 387GMG9FH5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1693-5Nightime Cough and Bronchial1 in 1 CARTONSYRUP14
53499-1693-5Nightime Cough and Bronchial120 mL in 1 BOTTLE, PLASTICSYRUP1204
53499-1693-9Nightime Cough and Bronchial1 in 1 CARTONSYRUP14
53499-1693-9Nightime Cough and Bronchial240 mL in 1 BOTTLE, PLASTICSYRUP2404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1693NIGHTIME 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]2Current NDC, 4 package rows20241006_b3899e48-2db8-4deb-b976-eb143b6223dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-1693-5534991693051 BOTTLE, PLASTIC in 1 CARTON (53499-1693-5) / 120 mL in 1 BOTTLE, PLASTIC2023-03-03NoNoCurrent
53499-1693-9534991693091 BOTTLE, PLASTIC in 1 CARTON (53499-1693-9) / 240 mL in 1 BOTTLE, PLASTIC2023-03-03NoNoCurrent