Dolodent

Arnica Montana, Chamomilla, Hecla Lava, Hypericum, Asafoedida

Pharmadel Llc
Human Otc Drug
NDC 55758-324

Dolodent also known as Arnica Montana, Chamomilla, Hecla Lava, Hypericum, Asafoedida is a human otc drug labeled by 'Pharmadel Llc'. National Drug Code (NDC) number for Dolodent is 55758-324. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Dolodent drug includes Arnica Montana - 30 [hp_X]/mL Chamomile - 30 [hp_X]/mL Ferula Assa-foetida Resin - 6 [hp_X]/mL Hekla Lava - 30 [hp_X]/mL Hypericum Perforatum - 30 [hp_X]/mL . The currest status of Dolodent drug is Active.

Drug Information:

Drug NDC:	55758-324
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Dolodent
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Arnica Montana, Chamomilla, Hecla Lava, Hypericum, Asafoedida
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Pharmadel Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ARNICA MONTANA - 30 [hp_X]/mL CHAMOMILE - 30 [hp_X]/mL FERULA ASSA-FOETIDA RESIN - 6 [hp_X]/mL HEKLA LAVA - 30 [hp_X]/mL HYPERICUM PERFORATUM - 30 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	BUCCAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Nov, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Pharmadel LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	O80TY208ZW FGL3685T2X W9FZA51AS1 C21158IIRK XK4IUX8MNB
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
55758-324-15	1 BOTTLE in 1 BOX (55758-324-15) / 15 mL in 1 BOTTLE	15 Mar, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Dolodent

Arnica Montana, Chamomilla, Hecla Lava, Hypericum, Asafoedida

Liquid
Pharmadel LLC
NDC: 55758-324

Purpose:

Active ingredients** (hpus) purposes* arnica montana 30x pain in the tooth, with inflammation chamomilla vulgaris 30x irritation, toothache, sore gums hekla lava 30x tooth sensitive to pressure, with swollen gums hypericum perforatum 30x sharp shooting pain, due to toothache asa foetida 6x cavity pain **the letters hpus indicate that this ingredient is officially included in the homeopathic pharmacopeia of the united states.

Product Elements:

Dolodent arnica montana, chamomilla, hecla lava, hypericum, asafoedida water arnica montana arnica montana chamomile chamomile clove oil ferula assa-foetida resin ferula assa-foetida resin hypericum perforatum hypericum perforatum glycerin propolis wax polysorbate 20 hekla lava hekla lava

Indications and Usage:

Uses* for the temporary relief of symptoms associated with a cavity until a dentist can be seen other dental procedures

Warnings:

Warnings do not use if you are allergic to any ingredients in this product when using this product use only in teeth with persistent, throbbing pain a dentist must be seen as soon as possible whether or not the pain is relieved toothaches and open cavities indicate serious problems which need prompt attention by a dentist stop use and ask your doctor or dentist if symptoms persist more than 2 days or reoccur inflammation, fever or infection develop if pregnant or breastfeeding, seek professional advice before taking this product. keep this and all medicines out of the reach of children. in case of an accidental overdose, get medical help or contact a poison control center right away.

Do Not Use:

When Using:

When using this product use only in teeth with persistent, throbbing pain a dentist must be seen as soon as possible whether or not the pain is relieved toothaches and open cavities indicate serious problems which need prompt attention by a dentist

Dosage and Administration:

Directions shake bottle well before each use adult and children 12 years of age and over: rinse the tooth with water to remove any food particles from the cavity or mouth moisten a small piece of cotton or gauze with 2-3 drops of the medication place in the area for about 1 minute repeat as needed children under 12 years of age: consult the advice and supervision of a dentist or doctor

Stop Use:

Stop use and ask your doctor or dentist if symptoms persist more than 2 days or reoccur inflammation, fever or infection develop

Package Label Principal Display Panel:

Principal display panel dolodent pp

Further Questions:

Question & comments? +1-866-359-3478 (m-f) 9am to 5pm est or www.pharmadel.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.