Over-the-counter medicine

Allantoin

Allantoin 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 allantoin FDA label on DailyMed (effective August 5, 2025); every allantoin label on DailyMed.

Highlights of the record

FDA label of August 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin
helps prevent and protect from the drying effects of wind and cold weather

Forms and strengths

1 mg
0.005 mg/g
0.0075 g/g
0.045 g/4.455g
0.25 g/50g
0.3 g/100ml
0.5 g/100g
0.5 mg/100g
0.6 g/100g
0.85 g/118.76g
1 g/108.48g
1 g/100g

Cream; gel; ointment; salve; patch.

On the market

Generic approvals: No generic approved
Labelers listed (NDC): 45 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: 3,292 through July 30, 2026

What is allantoin used for?

From the label: indications and usage
helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin
helps prevent and protect from the drying effects of wind and cold weather

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

Herpes and shingles

From other allantoin labels
Herpes and shingles: Relieves dryness and softens cold sores and fever blisters.

Source: FDA drug label (Earthmed Lip Balm Strawberry Rhubarb), Earthmed LLC, effective August 5, 2025 (SPL set 3b54eea1-2e09-2ee1-e063-6294a90a52e5), via openFDA; the full label on DailyMed

Is there a generic for allantoin?

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

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

What does the allantoin label say about other medicines?

The allantoin label names no other medicine on this site. The labels of 1 other medicine name allantoin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name allantoin

Rasburicase

Check allantoin against other medicines

Source: FDA drug label (Earthmed Lip Balm Strawberry Rhubarb), Earthmed LLC, effective August 5, 2025 (SPL set 3b54eea1-2e09-2ee1-e063-6294a90a52e5), via openFDA; the full label on DailyMed

What do FAERS reports show for allantoin?

The FDA Adverse Event Reporting System holds 3,292 reports that list allantoin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 453 are coded as a death and 1,430 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

Nausea411
Vomiting290
Condition Aggravated (a use or a product term, not a reaction)238
Dyspnoea217
Drug Ineffective (a use or a product term, not a reaction)213
Abdominal Pain207
Somnolence195
Fatigue179

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

What else is labeled for the same conditions as allantoin?

3 other medicines are given the same way (topical) and in the same FDA class as allantoin or labeled mainly for the same use (herpes and shingles), the same class first. Herpes and shingles lists all 15 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (topical)	Pharmacy cost	Shortage
Acyclovir	Herpes and shingles	19 labelers	$0.346 per gram 5% ointment	No current entry
Penciclovir	Herpes and shingles	3 labelers	$52.15 per gram 1% cream	No current entry
Acyclovir and hydrocortisone	Herpes and shingles	none listed	n/a	No current entry

Every medicine labeled for the same conditions as allantoin

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

What next?

Alternatives to allantoin: 3 medicines for the same use
Allantoin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other