NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL

Manufacturer: Rebel Distributors Corp
Effective date: 2011-01-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:11:06

Label at a glance#

ProductNystatin

Active ingredientNYSTATIN

Label structure12 sections

Indications and uses

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

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: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). T...

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:

This is an image of the structural formula for Nystatin.

Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid for pH adjustment.

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 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 reported.

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

CHILDREN AND ADULTS: 4–6 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, NDC 21695-643-60, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in 60 mL bottles with calibrated dropper.

Storage

STORAGE AND HANDLING SECTION

Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]; avoid freezing.

SPL UNCLASSIFIED SECTION

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8083097
R6/09-R0

Repackaged by:

REBEL DISTRIBUTORS CORP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312055	nystatin 100,000 UNT/mL Oral Suspension	PSN	1
312055	nystatin 100000 UNT/ML Oral Suspension	SCD	1
312055	nystatin 100,000 UNT/ML Oral Suspension	SY	1
312055	nystatin 500,000 UNT per 5 ML Oral Suspension	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NYSTATIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-643-60	2019-09-24	C162847	48780-1	934fe258-4845-48b1-e053-8cdaa90a720a	NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-643-60	Nystatin	60 mL in 1 BOTTLE, DROPPER	SUSPENSION	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-643	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110113_29ccf947-91c1-405a-aba6-5889e3c75d70.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-643-60	ML - Milliliter	21695-643	20738cb3-086c-472e-b196-a47c69fed8bf	1	2012-07-24
0603-1481-49	ML - Milliliter	0603-1481	1b0e5187-a61c-49a2-8770-ed137e2f0d73	1	2012-07-24
0603-1481-58	ML - Milliliter	0603-1481	c53f8969-0b36-4431-8610-50917d22273a	1	2012-07-24

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
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	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 CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	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
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SODIUM CITRATE
SUCROSE
ANHYDROUS CITRIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21695-643	21695-643-60
0603-1481

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	K679OBS311	IACT
GLYCERIN	PDC6A3C0OX	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SUCROSE	C151H8M554	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	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 · 468 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		48 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / BUCCAL		9 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CREAM / TOPICAL		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	AEROSOL, FOAM / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / SUBCUTANEOUS		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, EXTENDED RELEASE / ORAL		933 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYSTEM / TOPICAL		1680 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 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 · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
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.

Product history page 1 of 2 · 43 observed 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
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#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
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.

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
29ccf947-91c1-405a-aba6-5889e3c75d70			29ccf947-91c1-405a-aba6-5889e3c75d70	2011-01-03	Adverse reactions	Exact identifier spl id: 29ccf947-91c1-405a-aba6-5889e3c75d70 spl set id: 29ccf947-91c1-405a-aba6-5889e3c75d70

Reported adverse events (FAERS/openFDA)#

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