57955-5638 NDC - SLEEP AID (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, KALI PHOSPHORICUM, IGNATIA AMARA, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA, VALERIANA OFFICINALIS.)

Drug Information

Product NDC: 57955-5638
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, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus, Pulsatilla, 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:	8/16/2022
End Marketing Date:	8/1/2025

Package Information

No.	Package Code	Package Description	Billing Unit
1	57955-5638-2	1 BOTTLE, SPRAY in 1 CARTON (57955-5638-2) / 59 mL in 1 BOTTLE, SPRAY

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	57955-5638	The 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 NAME	HUMAN OTC DRUG	Indicates 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 NAME	Sleep Aid	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus, Pulsatilla, 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 NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/16/2022	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	8/1/2025	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product 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 NAME	King Bio Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACONITUM 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; VALERIAN	An 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 STRENGTH	10; 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 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]

Drug Information

Labeler Information

Package Information

NDC Record

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