NDC 36800-270 Top Care Castor Oil

Castor Oil

NDC Product Code 36800-270

NDC Product Information

Top Care Castor Oil with NDC 36800-270 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Top Care Castor Oil is castor oil. The product's dosage form is oil and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Top Care Castor Oil 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.

  • CASTOR OIL 1 mg/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)

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: Topco Associates Llc
Labeler Code: 36800
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-16-2019 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.

Top Care Castor Oil Product Label Images

Top Care Castor Oil 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

Castor Oil

Otc - Purpose

Stimulant Laxative

Indications & Usage

For the temporary relief of occasional constipation. Bowel movement is generally produced in 6 to 12 hours.

Warnings

Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Otc - Keep Out Of Reach Of Children

In case of accidental overdose, seek profssional assistance or contact a Poison Control Center immediately.

Dosage & Administration

Preferably take on an empty stomach. May be taken with juice to improve taste.Adults and children 12 yrs. of age and older: 1 to 4 tablesponfuls in a single daily dose or as directed by a doctor.Children 2 to under 12 yrs. of age: 1 to 3 teaspoonfuls in a single dose or as directed by a doctor.Children under 2 yrs. of age: Consult a doctor before use.

Inactive Ingredient

None

* Please review the disclaimer below.

Previous Code
36800-268
Next Code
36800-272