Verifying…
Home / Drug A–Z / Nystatin Oral Drops

Nystatin Oral Drops

NAFDAC Reg. No. B4-8497 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Nystatin Oral Drops
NAFDAC number
B4-8497
Active ingredient
Nystatin
Strength
100 mg/mL
Form
Drops
Pack size
1 x 30 mL (in bottle)
Manufacturer
Not listed
Applicant (holder)
Mazhar Brothers Nigeria Limited
Approved
30 Nov 2023
Status
Active View on NAFDAC ↗
Registration valid to
29 Nov 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Nystatin Oral Drops is on the NAFDAC register with an active registration (B4-8497). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Nystatin Oral Drops is used for

From the official U.S. FDA label for nystatin, the active ingredient registered with NAFDAC.

What it is used for

Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.

Possible side effects

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. [see PRECAUTIONS: General ].

Do not use if

Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.

Warnings

PRECAUTIONS General Nyamyc® (Nystatin Topical Powder, USP) should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens. …

Pregnancy & breastfeeding

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nyamyc® (Nystatin Topical Powder, USP) should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Storage

STORAGE Nyamyc® (Nystatin Topical Powder, USP) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat (40°C/104°F). Keep tightly closed. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Nystatin Oral Drops

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Nystatin Oral Drops

What is in Nystatin Oral Drops?

Nystatin Oral Drops contains Nystatin (100 mg/mL), as drops, according to its NAFDAC registration record.

Is Nystatin Oral Drops registered with NAFDAC?

Yes. Nystatin Oral Drops is listed on the NAFDAC register under registration number B4-8497, and its registration is active as of 6 November 2026.

Has Nystatin Oral Drops been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Nystatin Oral Drops in our automatically synced alert list.

How can I check that my pack of Nystatin Oral Drops is genuine?

Run a free authenticity scan with the NAFDAC number B4-8497, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Nystatin Oral Drops used for?

Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use. (Summarised from the official U.S. FDA label for nystatin. Always follow your doctor or pharmacist.)

Patient reviews

–No reviews yet
5★
0
4★
0
3★
0
2★
0
1★
0
Have you used Nystatin Oral Drops? Share your experience to help other patients. Sign in to review

Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.