Indications and uses
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Nystatin Oral Suspension USP [100,000 units per mL] I0868C0622 R06/22
- Manufacturer
- Major Pharmaceuticals | PAI Holdings, LLC
- Effective date
- 2026-02-23
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-05-31 22:07:01
Label at a glance#
ProductNystatin
Active ingredientNYSTATIN
Label structure12 sections
Dosage and administration
2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be re...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx Only
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:
Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.
CLINICAL PHARMACOLOGY
Pharmacokinetics
Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
Microbiology
Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
INDICATIONS AND USAGE
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
CONTRAINDICATIONS
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
PRECAUTIONS
General
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
Pregnancy
Teratogenic Effects Category C
Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
Pediatric Use
ADVERSE REACTIONS
Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General).
Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.
OVERDOSAGE
Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
DOSAGE AND ADMINISTRATION
INFANTS
2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).
NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.
CHILDREN AND ADULTS
4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.
Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.
HOW SUPPLIED
Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:
NDC 0904-7276-41: 5 mL unit dose cup
NDC 0904-7276-92: Case contains 50 unit dose cups of 5 mL, packaged in 5 trays of 10 unit dose cups each
NDC 0904-7276-70: Case contains 100 unit dose cups of 5 mL, packaged in 10 trays of 10 unit dose cups each
Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.
SPL UNCLASSIFIED SECTION
Distributed by:
MAJOR
® PHARMACEUTICALS
Indianapolis, IN 46268
R06/22
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
Major ®
NDC 0904-7276-41
Nystatin
Oral Suspension, USP
500,000 units / 5 mL
Alcohol ≤ 1% v/v SHAKE WELL
Delivers 5 mL ∙ See insert
For Institutional Use Only ∙ Rx Only
MAJOR ® PHARMACEUTICALS
Indianapolis, IN 46268
F0868C050624
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NYSTATIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0309047276417 | GTIN-13: 0309047276417 EAN-13: 0309047276417 GTIN-12: 309047276417 UPC-A: 309047276417 GTIN storage (14 digits): 00309047276417 | nystatin-2.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| 544f8e8d-6389-eeeb-9586-aa447c08dcc7 | Product name | 5 | 20210614 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 854ec07b-1cd7-a5db-235a-7aa24d3cf97a | Product name | 3 | 20180628 |
| 19b9f4c1-15e9-edcc-4c16-f01ecfb5c549 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7276-41 | Nystatin | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 7 | |
| 0904-7276-70 | Nystatin | 10 in 1 CASE | SUSPENSION | 10 | 7 | |
| 0904-7276-70 | Nystatin | 10 in 1 TRAY | SUSPENSION | 10 | 7 | |
| 0904-7276-92 | Nystatin | 5 in 1 CASE | SUSPENSION | 5 | 7 | |
| 0904-7276-92 | Nystatin | 10 in 1 TRAY | SUSPENSION | 10 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7276-41 | ML - Milliliter | 0904-7276 | 96e2ec22-526d-48c6-88ae-1ae44083a2af | 1 | 2022-12-07 |
| 0904-7276-70 | ML - Milliliter | 0904-7276 | 10302933-43ab-48c8-a467-039534481bd1 | 1 | 2022-12-07 |
| 0904-7276-92 | ML - Milliliter | 0904-7276 | 2a070892-5792-41ba-aff7-624e85e3245b | 1 | 2022-12-07 |
Products#
Every source-derived product name is available through these pages.
- Nystatin
- ALCOHOL
- CITRIC ACID MONOHYDRATE
- D&C YELLOW NO. 10
- FD&C RED NO. 40
- GLYCERIN
- MAGNESIUM ALUMINUM SILICATE
- METHYLPARABEN
- DIBASIC POTASSIUM PHOSPHATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-7276 | 0904-7276-41, 0904-7276-92, 0904-7276-70 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NYSTATIN | BDF1O1C72E | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| DIBASIC POTASSIUM PHOSPHATE | CI71S98N1Z | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCROSE | C151H8M554 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203621-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203621-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203621-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2016-01-07 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203621-001 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A203621-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203621-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203621-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203621-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203621-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203621-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203621-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203621-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203621-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203621-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203621-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203621-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203621-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203621-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203621-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203621-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203621-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203621-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203621-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203621-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203621-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203621-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203621-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203621-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203621-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203621-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203621-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203621-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203621-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203621-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203621-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203621-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203621-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203621-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203621-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203621-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203621-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203621-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203621-001 | AA | 1 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nystatin | NYSTATIN | Major Pharmaceuticals | 17b9e33d-da9c-467a-bbc4-9e257727f19a | 2026-02-23 | Adverse reactions | 0904-7276-41 0904-7276-70 0904-7276-92 0904-7276 00904727670 00904727692 00904727641 764e2a6a-00ef-4340-8810-9537bae3b0be 17b9e33d-da9c-467a-bbc4-9e257727f19a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.