FDA.reportPublic FDA data

Cough and Bronchial Nighttime

Product NDC
53499-1627
Requested package NDC
53499-1627-8
11-digit product format
534991627
Labeler code
53499
Product ID
53499-1627_01b5e098-5ae0-4462-bfb7-d56e9d1d9fd9
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, ALFALFA, ARABICA COFFEE BEAN, MEDICAGO SATIVA LEAF, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-07-22
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; MEDICAGO SATIVA LEAF; ALFALFA; ARABICA COFFEE BEAN
Active strength
3; 3; 6; 3; 6; 2; 2; 7 [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], 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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cough and Bronchial Nighttime
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
MEDICAGO SATIVA LEAF2 [hp_X]/120mL
ALFALFA2 [hp_X]/120mL
ARABICA COFFEE BEAN7 [hp_X]/120mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 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
HY3L927V6MInternal UNII lookup
DJO934BRBDInternal UNII lookup
3SW678MX72Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31445469-8f7f-4729-8128-fc53d5e5ab06Available on FDA.report

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 Bronchial NighttimeACONITUM NAPELLUS, ALFALFA, ARABICA COFFEE BEAN, MEDICAGO SATIVA LEAF, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America, Inc.31445469-8f7f-4729-8128-fc53d5e5ab062026-07-22WarningsExact identifier
ndc (package): 53499-1627-8
ndc (product): 53499-1627
ndc11 (package): 53499162708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-1627-8534991627081 BOTTLE, PLASTIC in 1 CARTON (53499-1627-8) / 240 mL in 1 BOTTLE, PLASTIC2026-07-22NoNoCurrent