DESCRIPTION SECTION
Nystatin Oral Suspension, USP
- Manufacturer
- TriRx Huntsville Pharmaceutical Services, LLC
- Effective date
- 2023-01-10
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:41:10
Label at a glance#
ProductNystatin
Active ingredientNYSTATIN
Label structure11 sections
Label contents#
Full prescribing information#
CLINICAL PHARMACOLOGY SECTION
INDICATIONS & USAGE SECTION
CONTRAINDICATIONS SECTION
PRECAUTIONS SECTION
ADVERSE REACTIONS SECTION
OVERDOSAGE SECTION
DOSAGE & ADMINISTRATION SECTION
HOW SUPPLIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Nystatin
- Nystatin Oral Suspension
- CARBOXYMETHYLCELLULOSE SODIUM
- ANHYDROUS CITRIC ACID
- WATER
- ALCOHOL
- GLYCERIN
- METHYLPARABEN
- PROPYLPARABEN
- CHERRY
- SUCROSE
- SACCHARIN SODIUM
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80432-003 | 80432-003-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| WATER | 059QF0KO0R | IACT |
| NYSTATIN | BDF1O1C72E | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| CHERRY | BUC5I9595W | IACT |
| SUCROSE | C151H8M554 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | 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 |
|---|---|---|---|---|---|---|---|
| A065148-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065148-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A065148-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065148-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065148-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065148-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065148-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065148-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065148-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065148-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065148-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065148-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065148-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065148-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065148-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065148-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065148-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065148-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065148-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065148-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065148-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065148-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065148-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065148-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065148-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065148-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065148-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065148-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065148-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065148-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065148-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065148-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065148-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065148-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065148-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065148-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065148-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065148-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065148-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065148-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065148-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065148-001 | AA | 1 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| 1f7d60cd-389e-f973-e063-6294a90a7376 | b95ce95e-ea57-99d5-e053-2a95a90ab217 | 2024-08-12 | Adverse reactions | b95ce95e-ea57-99d5-e053-2a95a90ab217 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.