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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Bronchial DaytimeACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America, Inc.ab0a4fd6-2311-4dd4-a146-949b86bfb4e72026-05-14WarningsExact identifier
ndc (product): 53499-1625

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 UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
T7J046YI2BInternal UNII lookup
1MBW07J51QInternal UNII lookup
1PIP394IIDInternal UNII lookup
387GMG9FH5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab0a4fd6-2311-4dd4-a146-949b86bfb4e7Available on FDA.report

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