70558-0011 NDC - SLEEP AID (ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH))

Drug Information

  • Product NDC: 70558-0011
  • Proprietary Name: Sleep Aid
  • Non Proprietary Name: Adenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Ubidecarenonum, L-Tryptophan, Melatonin, Pyrrole, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach)
  • Active Ingredient(s): 8 [hp_X]/mL ADENOSINE TRIPHOSPHATE DISODIUM; 10 [hp_X]/mL ARABICA COFFEE BEAN; 10 [hp_X]/mL ARSENIC TRIOXIDE; 10 [hp_X]/mL AVENA SATIVA FLOWERING TOP; 8 [hp_X]/mL LACTIC ACID, L-; 10 [hp_X]/mL MATRICARIA CHAMOMILLA WHOLE; 8 [hp_X]/mL MELATONIN; 10 [hp_X]/mL MERCURIC CHLORIDE; 8 [hp_X]/mL PANTOTHENIC ACID; 10 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP; 8 [hp_X]/mL PYRROLE; 30 [hp_C]/mL SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; 30 [hp_C]/mL SHIGELLA DYSENTERIAE; 10 [hp_X]/mL SILICON DIOXIDE; 8 [hp_X]/mL SUS SCROFA PINEAL GLAND; 8 [hp_X]/mL TRYPTOPHAN; 8 [hp_X]/mL UBIDECARENONE; 10 [hp_X]/mL ZINC VALERATE DIHYDRATE
  • 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: Pro Weight Loss Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/16/2021

Package Information

No. Package Code Package Description Billing Unit
170558-0011-130 mL in 1 BOTTLE, DROPPER (70558-0011-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC70558-0011The 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 NAMEAdenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Ubidecarenonum, L-Tryptophan, Melatonin, Pyrrole, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach)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 DATE7/16/2021This 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 NAMEPro Weight Loss Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEADENOSINE TRIPHOSPHATE DISODIUM; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; LACTIC ACID, L-; MATRICARIA CHAMOMILLA WHOLE; MELATONIN; MERCURIC CHLORIDE; PANTOTHENIC ACID; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZINC VALERATE DIHYDRATEAn 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 STRENGTH8; 10; 10; 10; 8; 10; 8; 10; 8; 10; 8; 30; 30; 10; 8; 8; 8; 10 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
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: 7/4/2025

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