NDC 51009-853 Toms Of Maine Vanilla Antiperspirant / Deodorant

Aluminum Chlorohydrate

NDC Product Code 51009-853

NDC CODE: 51009-853

Proprietary Name: Toms Of Maine Vanilla Antiperspirant / Deodorant 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: Aluminum Chlorohydrate 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

Color(s):
WHITE (C48325)

NDC Code Structure

  • 51009 - Tom's Of Maine, Inc.
    • 51009-853 - Toms Of Maine Vanilla Antiperspirant / Deodorant

NDC 51009-853-22

Package Description: 64 g in 1 CONTAINER

NDC Product Information

Toms Of Maine Vanilla Antiperspirant / Deodorant with NDC 51009-853 is a a human over the counter drug product labeled by Tom's Of Maine, Inc.. The generic name of Toms Of Maine Vanilla Antiperspirant / Deodorant is aluminum chlorohydrate. The product's dosage form is stick and is administered via topical form.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Toms Of Maine Vanilla Antiperspirant / Deodorant 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.


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.

  • PALM KERNEL OIL (UNII: B0S90M0233)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • DICAPRYLYL ETHER (UNII: 77JZM5516Z)
  • HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Tom's Of Maine, Inc.
Labeler Code: 51009
FDA Application Number: part350 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 11-01-2021 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.

Toms Of Maine Vanilla Antiperspirant / Deodorant Product Label Images

Toms Of Maine Vanilla Antiperspirant / Deodorant 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

Other

Drug Facts

DIST. BY TOM'S OF MAINE, INC., KENNEBUNK, ME 04043

Active Ingredient

Aluminum chlorohydrate (22%)

Purpose

Antiperspirant

Uses

  • Reduces underarm wetness48 hour protection

Warnings

For external use only

Otc - Do Not Use

Do not use on broken skin

Otc - Ask Doctor

Ask doctor before use if you have kidney disease

Otc - Stop Use

Stop use if rash or irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (412-390-3381)

Directions

Apply to underarms only

Inactive Ingredients

Elaeis guineensis (Palm) kernel oil, stearyl alcohol, dicaprylyl ether, hydrogenated soybean oil, hydrogenated castor oil, fragrance*, Olea europaea (Olive) leaf extract, maltodextrin

Questions?

1-800-FOR TOMS (1-800-367-8667)

* Please review the disclaimer below.