NYSTATIN ORAL SUSPENSION, USP

Manufacturer: Genus Lifescience Inc. | VistaPharm, Inc
Effective date: 2019-09-18
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:11:30

Label at a glance#

ProductNystatin

Active ingredientNystatin

Label structure12 sections

Indications and uses

Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.

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...

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

DESCRIPTION SECTION

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. In addition, the yellow opaque suspension contains the following inactive ingredients: Alcohol (0.5% v/v), USP, Alcohol free Bubble Gum 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

CLINICAL PHARMACOLOGY SECTION

Pharmacokinetics

PHARMACOKINETICS SECTION

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

MICROBIOLOGY SECTION

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

INDICATIONS & USAGE SECTION

Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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

PREGNANCY SECTION

Teratogenic Effects Category C

TERATOGENIC EFFECTS SECTION

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

NURSING MOTHERS SECTION

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

PEDIATRIC USE SECTION

See DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

OVERDOSAGE SECTION

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 or superinfections (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Infants

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

HOW SUPPLIED SECTION

Nystatin Oral Suspension, USP, 100,000 Nystatin units per mL, is available as a bubble gum flavored, yellow opaque, ready-to-use suspension.

Nystatin Oral Suspension, USP, is available as follows:

NDC 64950-230-06: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper;

NDC 64950-230-48: 16 fl. oz. bottle (480 mL).

Storage

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]

AVOID FREEZING

SPL UNCLASSIFIED SECTION

Rx Only

Manufactured By:
VistaPharm, Inc.
Largo, FL 33771

Distributed By:
Lehigh Valley Technologies, Inc.
Allentown, PA 18102

VP2129
10/13

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64950-230-06

NYSTATIN ORAL
SUSPENSION, USP

100,000 units per mL
Contains alcohol 0.5% v/v

Bubblegum Flavored

SHAKE WELL BEFORE USING

NET: 2 fl. oz. (60 mL)

with calibrated dropper

At the time of dispensing replace cap
with safety cap dropper

Rx
only
VP2128

Manufactured by: VistaPharm, Inc. Largo, FL 33771
Distributed by: Lehigh Valley Technologies, Inc. Allentown, PA 18102

L V T
Lehigh Valley Technologies, Inc.

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64950-230-48	ML - Milliliter	64950-230	4cc5d11e-75bc-4e52-bd22-69fa1d953e10	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	1
Nystatin	ACTIVE MOIETY	BDF1O1C72E	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Nystatin
Alcohol
Carboxymethylcellulose Sodium, Unspecified Form
Glycerin
Methylparaben
Propylparaben
Saccharin Sodium
Sodium Phosphate, Dibasic, Anhydrous
Sodium Phosphate, Monobasic, Unspecified Form
Sucrose
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64950-230	64950-230-06, 64950-230-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Nystatin	BDF1O1C72E	ACTIB
Alcohol	3K9958V90M	IACT
Carboxymethylcellulose Sodium, Unspecified Form	K679OBS311	IACT
Glycerin	PDC6A3C0OX	IACT
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Sodium Phosphate, Dibasic, Anhydrous	22ADO53M6F	IACT
Sodium Phosphate, Monobasic, Unspecified Form	3980JIH2SW	IACT
Sucrose	C151H8M554	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 8 · 464 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Alcohol	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / SUBCUTANEOUS		20 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, DELAYED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION/ DROPS / OPHTHALMIC		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, EMULSION / INTRAVENOUS	0.28 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	LIQUID / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / ORAL		140 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / NASAL	5 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRAMUSCULAR		36 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRALESIONAL		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065422-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	2011-03-07	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A065422-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065422-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065422-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065422-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065422-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065422-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065422-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065422-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065422-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065422-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065422-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065422-001	AA	1	`ea99ee380514…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f72780fd-8bd5-416c-93b7-461ca3c29c3f			d868575c-7eea-483e-ac35-151398bfa01e	2019-09-18	Adverse reactions	Exact identifier spl id: f72780fd-8bd5-416c-93b7-461ca3c29c3f spl set id: d868575c-7eea-483e-ac35-151398bfa01e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.