Cough and Bronchial

Product NDC
53499-1293
Requested package NDC
53499-1293-5
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cough and Bronchial
Listing expiration
2026-12-31

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
791a8da1-0de3-4798-bbc9-b3538ea28dd7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1293-5Cough and Bronchial1 in 1 CARTONSYRUP14
53499-1293-5Cough and Bronchial120 mL in 1 BOTTLE, PLASTICSYRUP1204
53499-1293-9Cough and Bronchial240 mL in 1 BOTTLE, PLASTICSYRUP2404
53499-1293-9Cough and Bronchial1 in 1 CARTONSYRUP14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1293COUGH AND BRONCHIAL (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) SYRUP [SCHWABE NORTH AMERICA]3Current NDC, 4 package rows20241009_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and BronchialACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America791a8da1-0de3-4798-bbc9-b3538ea28dd72025-12-08WarningsExact identifier
ndc (package): 53499-1293-5
ndc (product): 53499-1293
ndc11 (package): 53499129305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-1293-5534991293051 BOTTLE, PLASTIC in 1 CARTON (53499-1293-5) / 120 mL in 1 BOTTLE, PLASTIC2023-02-08NoNoCurrent