NDC 13838-1449 Alchemilla Comp.
Alchemilla Xanthochlora Flowering Top, Lycopus Europaeus Whole, Ribes Nigrum Leaf, Sage...

Product Information

What is NDC 13838-1449?

The NDC code 13838-1449 is assigned by the FDA to the product Alchemilla Comp. which is a human over the counter drug product labeled by Phytodyne Inc.. The generic name of Alchemilla Comp. is alchemilla xanthochlora flowering top, lycopus europaeus whole, ribes nigrum leaf, sage, and onion. The product's dosage form is solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 13838-1449-1 20 ml in 1 bottle, glass . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code13838-1449
Proprietary Name 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.
Alchemilla Comp.
Non-Proprietary Name 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.
Alchemilla Xanthochlora Flowering Top, Lycopus Europaeus Whole, Ribes Nigrum Leaf, Sage, And Onion
Product Type 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.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.
Phytodyne Inc.
Labeler Code13838
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-01-2005
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Alchemilla Comp.?


Product Characteristics

Color(s)BROWN (C48332)

Product Packages

NDC Code 13838-1449-1

Package Description: 20 mL in 1 BOTTLE, GLASS

Product Details

What are Alchemilla Comp. Active Ingredients?

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.

Alchemilla Comp. Active Ingredients UNII Codes

Alchemilla Comp. Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

* Please review the disclaimer below.

Alchemilla Comp. Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Otc - Purpose



For temporary relief of menstrual discomfort


Directions



Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.


Ingredients



Alchemilla vulgaris Ø (M) 30%, Lycopus europaeus Ø (N) 21%, Ribes nigrum Ø (N) 21%, Salvia officinalis Ø (N) 14%, Allium cepa 6X (M) 14%


Inactive Ingredient



Alcohol: 55


Tamper-Evident



Do not use if tamper evident strip is broken from base of cap.


Otc - Pregnancy Or Breast Feeding



Ask a doctor if you are pregnant or nursing.


Otc - Keep Out Of Reach Of Children



Keep away from children. In case of overdose, call a medical professional.


Principal Display Panel - 20 Ml Bottle Label



CERES®
Homeopathic Medicine

Alchemilla comp.

Use: For temporary relief of menstrual discomfort

Directions : Adults and children above 12 years: 2-5
drops 1-3 times daily in pure water before meals. Consult
a physician for use in children under 12 years of age.

0.67 fl.oz. (20ml)
Lot#:1234567A
EXP: 99.9999


* Please review the disclaimer below.