Indications and uses
Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.
NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL
- Manufacturer
- VistaPharm, LLC
- Effective date
- 2024-07-30
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:56:06
Label at a glance#
ProductNystatin
Active ingredientNYSTATIN
Label structure14 sections
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)...
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:
Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL.
Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP.
Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.
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, USP, 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
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 nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, LLC, at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 Nystatin Units per mL, cherry flavored, light creamy yellow, ready-to-use
suspension, is available as follows:
NDC 66689-037-01: 5 mL unit dose cup.
NDC 66689-037-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each.
NDC 66689-037-99: Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each.
Nystatin Oral Suspension, USP, 100,000 Nystatin units per mL, bubblegum flavored, yellow opaque, ready-to-use suspension is available as follows:
NDC 66689-008-02: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper.
NDC 66689-008-08: 8 fl. oz. bottle (237 mL).
NDC 66689-008-16: 16 fl. oz. bottle (480 mL).
Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
AVOID FREEZING.
SPL UNCLASSIFIED SECTION
Rx Only
Manufactured by:
Parsippany, NJ 07054
VP2053R3
07/24
PRINCIPAL DISPLAY PANEL - Unit Dose Cup
Nystatin
Oral Suspension, USP
500,000 units/5 mL
Alcohol not more than 1% v/v
SHAKE WELL. AVOID FREEZING.
Delivers 5 mL
Store at 20°–25°C (68°–77°F); see USP CRT conditions.
Manufactured by:
Largo, FL 33771, USA
Xact DOSE™
VistaPharm
Rx Only
VP2052R2
06/18
NDC 66689-037-01
PRINCIPAL DISPLAY PANEL - 60 mL
NDC 66689-008-02
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
Contains: Alcohol 0.5% v/v
(Bubblegum Flavored)
SHAKE WELL BEFORE USING
At The Time Of Dispensing Replace
Cap with Safety Cap Dropper
2 fl. oz.
(60 mL)
Rx only
VistaPharm®
NDC 66689-008-02
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
Contains: Alcohol 0.5% v/v
(Bubblegum Flavored)
SHAKE WELL BEFORE USING
2 fl. oz.
(60 mL)
Rx only
VistaPharm®
PRINCIPAL DISPLAY PANEL - 480 mL
NDC 66689-008-16
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
Contains: Alcohol 0.5% v/v
(Bubblegum Flavored)
SHAKE WELL BEFORE USING
16 fl. oz.
(480 mL)
Rx only
VistaPharm®
NDC 66689-008-16
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
(Bubblegum Flavored)
Contains: Alcohol 0.5% v/v
SHAKE WELL BEFORE USING
16 fl. oz.
(480 mL)
Rx only
VistaPharm®
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66689-008-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL |
| 66689-008-08 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL |
| 66689-008-16 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL |
| 66689-037-50 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL |
| 66689-037-99 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | NYSTATIN ORAL SUSPENSION, USP 100,000 Units/mL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66689-037-01 | ML - Milliliter | 66689-037 | 6a3ec317-9613-4f7d-9eee-828924af0e77 | 1 | 2012-07-24 |
| 66689-037-50 | ML - Milliliter | 66689-037 | e4cef736-2408-44ec-9137-907ae8c088f3 | 1 | 2012-07-24 |
| 66689-037-99 | ML - Milliliter | 66689-037 | 03cc26d6-50ff-4c03-b50e-feb5e3087fc1 | 1 | 2012-07-24 |
| 66689-008-02 | ML - Milliliter | 66689-008 | e63a7936-f9a8-4bfe-bce4-ea8756f5be60 | 1 | 2013-03-03 |
| 66689-008-16 | ML - Milliliter | 66689-008 | 96d8d758-76b3-4bd8-bb50-b0ffa58d8df4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Nystatin | ACTIVE INGREDIENT | BDF1O1C72E | 3 | |
| Nystatin | ACTIVE MOIETY | BDF1O1C72E | 3 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 3 | |
| Carboxymethylcellulose Sodium | INACTIVE INGREDIENT | K679OBS311 | 3 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 3 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 3 | |
| Saccharin Sodium Dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | 3 | |
| Sodium Phosphate, Dibasic, Anhydrous | INACTIVE INGREDIENT | 22ADO53M6F | 3 | |
| Sodium Phosphate, Monobasic, Monohydrate | INACTIVE INGREDIENT | 593YOG76RN | 3 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 3 |
Products#
Every source-derived product name is available through these pages.
- Nystatin
- METHYLPARABEN
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- GLYCERIN
- SACCHARIN SODIUM
- SUCROSE
- CARBOXYMETHYLCELLULOSE SODIUM
- ALCOHOL
- PROPYLPARABEN
- SODIUM PHOSPHATE, DIBASIC
- SODIUM PHOSPHATE, MONOBASIC
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66689-037 | 66689-037-01, 66689-037-50, 66689-037-99 |
| 66689-008 | 66689-008-02, 66689-008-08, 66689-008-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | FILM, SOLUBLE / ORAL | 0.05 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRAMUSCULAR | 30 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | TABLET, EXTENDED RELEASE / ORAL | 210 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | AEROSOL, FOAM / VAGINAL | 0.2 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYRUP / ORAL | 26.5 mg | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | CAPSULE, DELAYED RELEASE / ORAL | 43 mg | ||
| Sodium Phosphate, Monobasic, Monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 15.55 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION / INTRA-ARTICULAR | 28 mg | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1751 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, SUSPENSION / SOFT TISSUE | 3 mg | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, SOLUTION / INTRATHECAL | 1 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | SOLUTION/ DROPS / OPHTHALMIC | 1.4 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| Carboxymethylcellulose Sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, EXTENDED RELEASE / ORAL | 933 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| Sodium Phosphate, Monobasic, Monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | SOLUTION / TOPICAL | 0.46 %w/v | ||
| Sodium Phosphate, Dibasic, Anhydrous | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | LIQUID / INTRAVENOUS | 381 mg |
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 |
|---|---|---|---|---|---|---|---|
| A064142-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | ||
| A064142-002 | NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 |
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 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 1998-06-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | 2011-03-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1998-06-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064142-002 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2011-03-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1998-06-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1998-06-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1998-06-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1998-06-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1998-06-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064142-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 1998-06-25 | 87673890dc5c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064142-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064142-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064142-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064142-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064142-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064142-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064142-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064142-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064142-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064142-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064142-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064142-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064142-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064142-001 | AA | 1 | ea99ee380514… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064142-001 | AA | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064142-002 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064142-001 | AA | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064142-002 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064142-001 | AA | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064142-002 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064142-001 | AA | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A064142-002 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064142-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A064142-002 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064142-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064142-002 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064142-001 | AA | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A064142-002 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A064142-001 | AA | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A064142-002 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A064142-001 | AA | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A064142-002 | AA | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| 0d594ed4-b42c-447d-8b1e-67dcfbd27690 | 41034d7b-33a1-4d6d-b425-9cfefff8d518 | 2024-07-30 | Adverse reactions | 0d594ed4-b42c-447d-8b1e-67dcfbd27690 41034d7b-33a1-4d6d-b425-9cfefff8d518 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.