Checked
Fortify
menthol · Fortify is an over-the-counter drug containing menthol, made by 2 manufacturers.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 2
Directions See important warnings under 'When using this product'. Adults and children 12 years of age and older: rub on the throat and chest in a thick layer cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help...
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing09/02/2026Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per...Church & Dwight Co., Inc. · CGMP Deviations; FDA inspection of the contract manufacturer noted...
- Class IIDrugOngoing07/29/2026Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%)...Rohto-Mentholatum (Vietnam) Co., Ltd. · 8 products · Lack of Assurance of Sterility
- Class IIDrugOngoing04/22/2026exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag...Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · 14 products · This recall is being initiated following FDA's recommendation...
- Class IIDrugOngoing01/21/2026Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d)...GOLD STAR DISTRIBUTION INC · CGMP Deviations: Insanitary conditions including rodent...
- Class IIDrugOngoing12/03/2025Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120...CA BOTANA International, Inc. · 2 products · CGMP Deviations
Active ingredients
DRUG FACTS Active ingredient Menthol 2.7%
Purpose
Antitussive (Cough Suppressant) Uses Temporarily calms cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. Relieves the impulse to cough to help you rest.
Uses
Directions See important warnings under 'When using this product'. Adults and children 12 years of age and older: rub on the throat and chest in a thick layer cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth
Directions
Use up to three times daily or as directed by a doctor. Children under 12 years of age: ask a doctor.
Warnings
For external use only. Do not take by mouth or place in nostrils Flammable: Keep away from fire or flame.
Do not use
If epileptic with high blood pressure
Ask a doctor before use
Persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus).
When using this product
, do not heat microwave use near an open flame add to hot water or any container where heating water. May cause splattering and result in burns.
Stop use and ask a doctor
Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Pregnancy or breastfeeding
Do not use this product.
Keep out of reach of children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Inactive ingredients
Cinnamon oil, eucalyptus oil, melaleuca alternifolia (tea tree) leaf oil, pelargonium graveolens oil, peppermint oil, pine needle oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.
Questions?
1-877-275-7253 Distributed by: SAJE NATURAL WELLNESS 22 East 5th Ave. Vancouver, BC Canada V5T 1G8 | saje.com | @sajewellness | 1-877-275-7253 | Made in Canada
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Oil | 24 mg/mL | topical | 2 |
Manufacturers and labels
2 FDA labels
- Saje Natural Business Inc.Shown hereM012 · Label 01/13/2026 · NDC 70983-002Full label
- Natures Formulae Health Products Ltd.M012 · Label 12/29/2025 · NDC 69204-003Full label
Fortify: common questions
- What is Fortify used for?
- Directions See important warnings under 'When using this product'. Adults and children 12 years of age and older: rub on the throat and chest in a thick layer cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help...
- Is Fortify a prescription drug?
- No. Fortify is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Fortify?
- Yes. Other FDA-listed products with the same active ingredients include Honey Lemon Cough Drops, Menthol Cough Drops, Cherry Cough Drops, Sugar Free Honey Lemon Cough Drops.
- Who makes Fortify?
- 2 manufacturers list Fortify with the FDA, including Saje Natural Business Inc., Natures Formulae Health Products Ltd.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/13/2026 · Label text is shown as published by the manufacturer. Not medical advice