Quasi-Drug Product Report for Mouth Fresheners (Gargle, Oral Spray) — Manufacturing Business Report and Standards for Efficacy Claims

Procedure

1. 1. Check whether the product is a mouth freshener

   If the purpose is to prevent bad breath and relieve unpleasant sensations in the mouth, it is a mouth freshener. A preparation containing more than 0.75% hydrogen peroxide falls outside the scope of mouth fresheners, so check the formulation first.

2. 2. Determine whether a permit or a report applies

   Products listed in an official compendium, products for which the Ministry of Food and Drug Safety has publicly notified the specifications and test methods, and products that conform to the standard manufacturing criteria are subject to a product report. If you use ingredients or claim efficacy outside this scope, a product permit and a safety and efficacy review are required.

3. 3. Decide on a manufacturing business report or a consignment structure

   To manufacture the product yourself, meet the facility standards and file a manufacturing business report. Even when you entrust manufacturing to another manufacturer, decide before the contract which party will file the product report or obtain the product permit.

4. 4. Submit the product report form and supporting data

   State the active ingredients and their content, the dosage form, the specifications and test methods, the efficacy and effects, the usage and dosage, and the precautions for use, and submit the form with supporting data attached. The efficacy and effects follow matters already permitted or reported, or the wording of the standard manufacturing criteria.

5. 5. Check labeling and advertising

   Check that the wording on the container and packaging and in advertising does not exceed the reported scope of efficacy. To indicate other efficacy, such as prevention of tooth decay or improvement of gum disease, the product must go through a separate review suited to that efficacy.

Required documents

• Quasi-drug manufacturing business report form and facility-related documents (when manufacturing yourself)
• Product report form or product permit application form
• Raw materials and their quantities, and the manufacturing method
• Data on specifications and test methods
• Supporting data for the efficacy and effects, the usage and dosage, and the precautions for use
• Draft labeling for the container and packaging
• Consignment manufacturing contract (when manufacturing is entrusted)

Fees

Service fees in the industry for preparing the manufacturing business report and product report documents range from several hundred thousand won up to the 1,000,000 won range and vary with whether the product is subject to a report or to a permit and review, and with the number of products. We will advise you after a consultation based on the formulation and the draft labeling.

See fees and official charges for this service →

Legal basis and review date

• Pharmaceutical Affairs Act, Article 31, paragraph (4)
• Pharmaceutical Affairs Act, Article 42
• Designation of the Scope of Quasi-Drugs (Public Notice of the Ministry of Food and Drug Safety)
• Regulations on Product Permits, Reports and Review of Quasi-Drugs, Article 3

Checked against the statutes on 2026-10-05

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• If the wording in advertising or on packaging exceeds the reported efficacy, the product report must be filed again or the labeling corrected.
• For consignment manufacturing, first decide, before the contract, which party will file the product report.

Frequently asked questions