68466-0009 NDC - COUGH AND BRONCHIAL NIGHTTIME SYRUP (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN)

Drug Information

Product NDC: 68466-0009

Proprietary Name: Cough and Bronchial Nighttime Syrup

Non Proprietary Name: ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN

Active Ingredient(s):
  • 3 [hp_X]/118mL ACONITUM NAPELLUS;
  • 6 [hp_X]/118mL ARABICA COFFEE BEAN;
  • 3 [hp_X]/118mL BRYONIA ALBA ROOT;
  • 6 [hp_C]/118mL CALCIUM SULFIDE;
  • 1 [hp_X]/118mL MEDICAGO SATIVA LEAF;
  • 1 [hp_X]/118mL OAT;
  • 3 [hp_X]/118mL SPONGIA OFFICINALIS SKELETON, ROASTED;
  • 6 [hp_C]/118mL TIN


Administration Route(s): ORAL; ORAL

Dosage Form(s): SYRUP

Pharmacy Class(es):
  • 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]

Labeler Information

Labeler Name: Schwabe Mexico S.A. DE C.V.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/1/2004

Package Information

No. Package Code Package Description Billing Unit
168466-0009-51 BOTTLE, PLASTIC in 1 CARTON (68466-0009-5) / 120 mL in 1 BOTTLE, PLASTIC
268466-0009-91 BOTTLE, PLASTIC in 1 CARTON (68466-0009-9) / 240 mL in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC68466-0009The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMECough and Bronchial Nighttime SyrupThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESYRUPThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORAL; ORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/1/2004This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMESchwabe Mexico S.A. DE C.V.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS; ARABICA COFFEE BEAN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; MEDICAGO SATIVA LEAF; OAT; SPONGIA OFFICINALIS SKELETON, ROASTED; TINAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH3; 6; 3; 6; 1; 1; 3; 6 
ACTIVE INGRED UNIT[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL 
PHARM CLASSESAllergens [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] 

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This page was last updated on: 2/1/2023