NDC 0220-9078 Cyclease Cramp

Black Cohosh, Citrullus Colocynthis Fruit Pulp, Esium Phosphate, Dibasic Trihydrate

NDC Product Code 0220-9078

NDC CODE: 0220-9078

Proprietary Name: Cyclease Cramp 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: Black Cohosh, Citrullus Colocynthis Fruit Pulp, Esium Phosphate, Dibasic Trihydrate 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.

Product Characteristics

WHITE (C48325)
Shape: ROUND (C48348)
9 MM
Score: 1

NDC Code Structure

  • 0220 - Laboratoires Boiron

NDC 0220-9078-04

Package Description: 60 TABLET in 1 BLISTER PACK

NDC Product Information

Cyclease Cramp with NDC 0220-9078 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Cyclease Cramp is black cohosh, citrullus colocynthis fruit pulp, esium phosphate, dibasic trihydrate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Laboratoires Boiron

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.

Cyclease Cramp 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.

  • BLACK COHOSH 6 [hp_C]/1

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.


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: Laboratoires Boiron
Labeler Code: 0220
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: 07-08-1992 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: 12-31-2021 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.

Cyclease Cramp Product Label Images

Cyclease Cramp 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

Otc - Active Ingredient

Cimicifuga racemosa 6C, Colcynthis 6C, Magnesia phosphorica 6C

Indications & Usage

Temporary relieves minor aches and pains associated with menstrual cramps.

Otc - Do Not Use

Do not use if glued carton en flaps are open or if the blister seal is broken

Dosage & Administration

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth every
15 minutes for 3 doses. Repeat as needed.

Children under 12 years of age: Not recommended

Inactive Ingredient

Croscarmellose sodium, lactose, magnesium stearate

How Supplied

60 tablets

Otc - Purpose

Cimicifuga racemosa 6C...Relieves menstrual cramps improved by lying down

Colcynthis 6C...Relieves menstrual cramps improved by bending over

Magnesia phosphorica 6C...Relieves menstrual cramps improved by warmth

Storage And Handling

Store at 68-77

o F

Otc - Questions

Questions, Comments





Boiron Information Center

6 campus boulevard

Newtown Square, PA


Otc - Stop Use

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Drug Interactions

Safe - no side effects - no drug interactions - works naturally with your body


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* Please review the disclaimer below.