NDC 49726-047 Restulex

Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum.

NDC Product Code 49726-047

NDC Code: 49726-047

Proprietary Name: Restulex What is the Proprietary Name?
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: Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum. What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 49726-047-60

Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Restulex with NDC 49726-047 is a a human over the counter drug product labeled by Hellolife, Inc.. The generic name of Restulex is bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla (pratensis) rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum.. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Hellolife, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
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.

Restulex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BUFO BUFO CUTANEOUS GLAND 10 [hp_X]/1
  • CAUSTICUM 10 [hp_X]/1
  • MATRICARIA CHAMOMILLA 10 [hp_X]/1
  • CROTALUS HORRIDUS HORRIDUS VENOM 10 [hp_X]/1
  • DIGITALIS 10 [hp_X]/1
  • LACHESIS MUTA VENOM 10 [hp_X]/1
  • LILIUM LANCIFOLIUM WHOLE FLOWERING 10 [hp_X]/1
  • ANEMONE PRATENSIS 10 [hp_X]/1
  • TOXICODENDRON PUBESCENS LEAF 10 [hp_X]/1
  • SULFUR 10 [hp_X]/1
  • LYCOSA TARANTULA 10 [hp_X]/1
  • VISCUM ALBUM FRUIT 10 [hp_X]/1
  • ZINC 10 [hp_X]/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hellolife, Inc.
Labeler Code: 49726
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
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.

Start Marketing Date: 10-10-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Restulex Product Label Images