NDC 75053-0005 Cerebellutem

Causticum, Absinthium, Ranunculus Glacialis, Theridion, Heloderma, Picrotoxinum, Succinum, Helleborus Niger

NDC Product Code 75053-0005

NDC CODE: 75053-0005

Proprietary Name: Cerebellutem 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: Causticum, Absinthium, Ranunculus Glacialis, Theridion, Heloderma, Picrotoxinum, Succinum, Helleborus Niger 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

  • 75053 - Nucleic Products, Llc

NDC 75053-0005-1

Package Description: 118 mL in 1 BOTTLE, DROPPER

NDC Product Information

Cerebellutem with NDC 75053-0005 is a a human over the counter drug product labeled by Nucleic Products, Llc. The generic name of Cerebellutem is causticum, absinthium, ranunculus glacialis, theridion, heloderma, picrotoxinum, succinum, helleborus niger. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Nucleic Products, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Cerebellutem 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.

  • CAUSTICUM 5 [hp_X]/mL
  • WORMWOOD 6 [hp_X]/mL
  • BECKWITHIA GLACIALIS WHOLE 10 [hp_X]/mL
  • THERIDION CURASSAVICUM 10 [hp_X]/mL
  • HELODERMA HORRIDUM VENOM 12 [hp_X]/mL
  • PICROTOXIN 16 [hp_X]/mL
  • AMBER 30 [hp_C]/mL
  • HELLEBORUS NIGER ROOT 30 [hp_C]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Nucleic Products, Llc
Labeler Code: 75053
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: 04-19-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Cerebellutem Product Label Images

Cerebellutem Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Causticum 5X, 30C, Absinthium 6X, 30C, Ranunculus Glacialis 10X, 30C, Theridion 10X, 30C, 200C, Heloderma 12X, 15X, 30C, 200C, Picrotoxinum 16X, 30C, Succinum 30C, Helleborus Niger 30C, 200C.

Indications:

Homeopathic medicine for the relief of symptoms related to dizziness, jitters and pain in base of head.Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.

Homeopathic medicine for the relief of symptoms related to dizziness, jitters and pain in base of head.Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breast-feeding, ask a health care professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if seal is broken or missing.This Product does not contain sugar, starch, salt, preservatives, artificial flavors or additives, and no soy or milk derivatives.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one full dropper up to 2 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

20% ethanol, purified water

Questions:

Distributed by:Nucleic Products, LLCPO Box 6856 Grove, OK 74344

Package Label Display:

NDC: 75053-0005-1Nu cleicCerebellutemHomeopathic MedicineFor Professional Use Only4 fl oz. (118 ml)

* Please review the disclaimer below.