57955-9986 NDC - SLEEP AID (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA, AND VALERIANA OFFICINALIS.)

Drug Information

  • Product NDC: 57955-9986
  • Proprietary Name: Sleep Aid
  • Non Proprietary Name: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Pulsatilla, and Valeriana officinalis.
  • Active Ingredient(s): 10 [hp_X]/59mL ACONITUM NAPELLUS WHOLE; 10 [hp_X]/59mL AESCULUS HIPPOCASTANUM FLOWER; 10 [hp_X]/59mL ARABICA COFFEE BEAN; 10 [hp_X]/59mL ARSENIC TRIOXIDE; 10 [hp_X]/59mL ATROPA BELLADONNA; 10 [hp_X]/59mL AVENA SATIVA FLOWERING TOP; 10 [hp_X]/59mL CAMPHOR (NATURAL); 10 [hp_X]/59mL CINCHONA OFFICINALIS BARK; 10 [hp_X]/59mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; 10 [hp_X]/59mL DIBASIC POTASSIUM PHOSPHATE; 10 [hp_X]/59mL HYOSCYAMUS NIGER; 10 [hp_X]/59mL PASSIFLORA INCARNATA FLOWERING TOP; 10 [hp_X]/59mL PHOSPHORUS; 10 [hp_X]/59mL PULSATILLA VULGARIS WHOLE; 10 [hp_X]/59mL STRYCHNOS IGNATII SEED; 10 [hp_X]/59mL VALERIAN
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: King Bio Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/15/2026

Package Information

No. Package Code Package Description Billing Unit
157955-9986-259 mL in 1 BOTTLE, SPRAY (57955-9986-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC57955-9986The 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 NAMESleep AidThe 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, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Pulsatilla, and Valeriana officinalis.The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/15/2026This 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 NAMEKing Bio Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS WHOLE; AESCULUS HIPPOCASTANUM FLOWER; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIBASIC POTASSIUM PHOSPHATE; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; STRYCHNOS IGNATII SEED; VALERIANAn 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 STRENGTH10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 
ACTIVE INGRED UNIT[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 
PHARM CLASSESAllergens [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] 

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This page was last updated on: 3/27/2026

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