Over-the-counter medicine

Levomenthol

Levomenthol is an over-the-counter medicine. No generic is listed in FDA's NDC Directory.

No generic listed
Over the counter

Check it at the source: the levomenthol FDA label on DailyMed (effective November 18, 2025); every levomenthol label on DailyMed.

Highlights of the record

FDA label of November 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat

Forms and strengths

2.7 mg
5.4 mg
5.8 mg
7 mg
7.5 mg
9 mg
20 mg
500 mg
0.04 mg/ml
5 g/100g
15 mg/ml
105 mg/ml

Lozenge; patch; gel; rinse; spray.

On the market

Generic approvals: No generic approved
Labelers listed (NDC): 7 of which 0 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 3,301 through July 30, 2026

What is levomenthol used for?

From the label: indications and usage
Temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat

Conditions named in the indications of levomenthol's FDA labels, with every medicine labeled for each:

Pain

From other levomenthol labels
Pain: Uses Temporarily relieves occasional minor irritation and pain due to: sore throat; sore mouth

Source: FDA drug label (Cough Drops Gems Flawless Honey Lemon Flavor 30ct), Riclan S.A., effective November 18, 2025 (SPL set 16f6d531-9298-4172-8d08-ecd87d6add76), via openFDA; the full label on DailyMed

Is there a generic for levomenthol?

No generic levomenthol is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for levomenthol?

The FDA Adverse Event Reporting System holds 3,301 reports that list levomenthol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 213 are coded as a death and 733 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)444
Pain (a use or a product term, not a reaction)273
No Adverse Event (a use or a product term, not a reaction)209
Fatigue195
Dyspnoea174
Headache (named in the label)167
Diarrhoea159
Pruritus151

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as levomenthol?

34 other medicines are given the same way (oral) and in the same FDA class as levomenthol or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Aspirin	Pain	none listed	$0.0142 per tablet 81 mg tablet	A presentation being discontinued
Acetaminophen and hydrocodone	Pain	38 labelers	$0.152 per tablet 10-325 mg tablet	No current entry
Diclofenac	Pain	67 labelers	$0.0619 per tablet 75 mg tablet	A presentation being discontinued
Oxycodone	Pain	34 labelers	$0.0884 per tablet 5 mg tablet	No current entry
Acetaminophen and oxycodone	Pain	30 labelers	$0.183 per tablet 7.5-325 mg tablet	A presentation being discontinued
Tramadol	Pain	40 labelers	$0.0248 per tablet 50 mg tablet	No current entry
Morphine	Pain	17 labelers	$0.226 per tablet 15 mg tablet	In shortage
Phenazopyridine	Pain	none listed	$0.154 per tablet 100 mg tablet	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does levomenthol compare with medicines for the same use?

1 side-by-side page set levomenthol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

Menthol

What next?

Levomenthol side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other