Cough and Bronchial Nighttime Syrup

Product NDC
68466-1009
11-digit product format
684661009
Labeler code
68466
Product ID
68466-1009_07539805-19f1-4b88-9520-1d462925b215
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; ORAL
Labeler
Schwabe Mexico S.A. DE C.V.
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
Cough and Bronchial Nighttime Syrup
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS3 [hp_X]/120mL
BRYONIA ALBA ROOT6 [hp_X]/120mL
CALCIUM SULFIDE3 [hp_X]/120mL
SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_C]/120mL
TIN1 [hp_X]/120mL
MEDICAGO SATIVA LEAF1 [hp_X]/120mL
OAT3 [hp_X]/120mL
ARABICA COFFEE BEAN6 [hp_C]/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
Z6J799EAJKInternal 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
00d38f6f-dbab-4bbd-84b5-9807ea9073f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68466-1009-5Cough and Bronchial Nighttime Syrup120 mL in 1 BOTTLE, PLASTICSYRUP1203
68466-1009-5Cough and Bronchial Nighttime Syrup1 in 1 CARTONSYRUP13
68466-1009-9Cough and Bronchial Nighttime Syrup1 in 1 CARTONSYRUP13
68466-1009-9Cough and Bronchial Nighttime Syrup240 mL in 1 BOTTLE, PLASTICSYRUP2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68466-1009COUGH AND BRONCHIAL NIGHTTIME SYRUP (ACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN) SYRUP [SCHWABE MEXICO S.A. DE C.V.]2Current NDC, 4 package rows20241006_00d38f6f-dbab-4bbd-84b5-9807ea9073f8.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 Bronchial Nighttime SyrupACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe Mexico S.A. DE C.V.00d38f6f-dbab-4bbd-84b5-9807ea9073f82025-12-04WarningsExact identifier
ndc (product): 68466-1009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68466-1009-5684661009051 BOTTLE, PLASTIC in 1 CARTON (68466-1009-5) / 120 mL in 1 BOTTLE, PLASTIC2023-03-03NoNoCurrent
68466-1009-9684661009091 BOTTLE, PLASTIC in 1 CARTON (68466-1009-9) / 240 mL in 1 BOTTLE, PLASTIC2023-03-03NoNoCurrent