FDA.reportPublic FDA data

Cough and Bronchial Daytime

Product NDC
53499-1625
11-digit product format
534991625
Labeler code
53499
Product ID
53499-1625_495817a1-a080-46ea-a5fb-14ca9b261fe5
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-05-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cough and Bronchial Daytime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS3 [hp_X]/120mL
BRYONIA ALBA ROOT3 [hp_X]/120mL
CALCIUM SULFIDE6 [hp_C]/120mL
SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]/120mL
TIN6 [hp_C]/120mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, T7J046YI2B, 1MBW07J51Q, 1PIP394IID, 387GMG9FH5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1625-4Cough and Bronchial Daytime1 in 1 CARTONSYRUP11
53499-1625-4Cough and Bronchial Daytime120 mL in 1 BOTTLE, PLASTICSYRUP1201
53499-1625-8Cough and Bronchial Daytime1 in 1 CARTONSYRUP11
53499-1625-8Cough and Bronchial Daytime240 mL in 1 BOTTLE, PLASTICSYRUP2401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-1625-4534991625041 BOTTLE, PLASTIC in 1 CARTON (53499-1625-4) / 120 mL in 1 BOTTLE, PLASTIC2026-05-14NoNoCurrent
53499-1625-8534991625081 BOTTLE, PLASTIC in 1 CARTON (53499-1625-8) / 240 mL in 1 BOTTLE, PLASTIC2026-05-14NoNoCurrent