Nystatin Oral Suspension, USP 100,000 units per mL

Manufacturer: Rebel Distributors Corp | PSS World Medical, Inc. | STAT RX USA LLC | Dispensing Solutions, Inc. | SCRIPT PAK | Keltman Pharmaceuticals, Inc. | Rebel Distirbutors Corp.
Effective date: 2012-10-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:16:41

Label at a glance#

ProductNystatin

Active ingredientNYSTATIN

Label structure10 sections

Indications and uses

Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans .

Dosage and administration

Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth). Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective. Local treatment should be continued at least 48 hour...

Contacts and useful links#

PhoneLabel contact1-800-262-9010

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety.

Its structural formula is:

Image of Structural Formula

C₄₇H₇₅NO₁₇ M.W. 926.13

Nystatin oral suspension, USP is a cherry-mint flavored, ready-to-use suspension. Each mL of nystatin oral suspension, USP contains 100,000 units of nystatin in a vehicle containing 50% w/v sucrose with the following inactive ingredients: alcohol (less than 1% v/v), carboxymethylcellulose sodium, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, and sodium citrate. Citric acid and/or sodium hydroxide may be used to adjust pH (5.3-7.5).

PRESERVATIVES ADDED: Methylparaben 0.12%, Propylparaben 0.03%

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Discontinue treatment with nystatin if sensitization or irritation is reported during use.

Nystatin is not effective in the treatment of systemic mycoses since it is not significantly absorbed from the gastrointestinal tract.

Information for Patients

INFORMATION FOR PATIENTS SECTION

Patient should be advised to retain nystatin in the mouth as long as possible and to continue its use for at least 2 days after symptoms have subsided.

There should be no interruption or discontinuation of the medication until the prescribed course of treatment is completed, even though symptomatic relief may occur within a few days.

If symptoms of local irritation develop, the physician should be notified immediately.

Laboratory Tests

LABORATORY TESTS SECTION

If there is a lack of therapeutic response, appropriate microbiological studies (e .g., KOH smears and/or cultures) should be repeated to confirm the diagnosis of candidiasis and rule out other pathogens before instituting another course of therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. In mice exposed to nystatin 50 mg/kg by injection, an increased incidence of chromosomal aberrations, consisting primarily of chromatid breaks, was observed in bone marrow cells. However, there have been no studies to determine the mutagenicity of orally-administered nystatin or its effects on fertility in males or females.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects

TERATOGENIC EFFECTS SECTION

Pregnancy Category C

SPL UNCLASSIFIED SECTION

Teratogenicity studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.

Nonteratogenic Effects

NONTERATOGENIC EFFECTS SECTION

In one rat reproductive study, nystatin was administered orally to pregnant rats in single doses of 100, 500, or 3000 mg/kg on the ninth day of gestation, or as multiple doses of 500 mg/kg/day on gestation days 1-20, 1-4, 7-10, 11-14, or 15-18. It was found that nystatin had a slight abortive effect when used during the whole period of pregnancy. No abnormalities were seen in surviving fetuses. Although no adverse effects or complications have been attributed to the use of intra-vaginal nystatin in neonates born to women treated during pregnancy, no similar studies evaluating complications of oral nystatin have been conducted.

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 section for pediatric dosing recommendations.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.

OVERDOSAGE

OVERDOSAGE SECTION

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth).

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

NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective.

Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.

HOW SUPPLIED

HOW SUPPLIED SECTION

Nystatin Oral Suspension USP, 100,000 units per mL, is available as a yellow, milky, ready-to-use suspension with a cherry-mint flavor in the following sizes:

60 mL bottles (with child-resistant calibrated dropper)

SHAKE WELL BEFORE USING.

Storage: Store between 15°-30°C (59°-86°F). PROTECT FROM FREEZING.

Dispense in a tight, light resistant container when dispensing from the original container.

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nystatin 100,00 Units/ml

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
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
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
42254-322-60	2019-09-24	C162847	48780-1	9350213a-3cc2-c013-e053-90daa90a1393	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
42254-322-60	Nystatin	60 mL in 1 BOTTLE, DROPPER	SUSPENSION	60		1
42254-322-60	Nystatin	1 in 1 CARTON	SUSPENSION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-322	NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20130329_8ce02e76-303c-4e06-a47e-0a7bbf46c3f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-322-60	ML - Milliliter	42254-322	552f0046-9251-42f2-85df-72ca31d92f84	1	2013-04-01
50383-587-16	ML - Milliliter	50383-587	aaac5690-86c2-4a39-8258-14113544d743	1	2012-07-24
50383-587-66	ML - Milliliter	50383-587	3534ff37-b61d-4e86-8aa7-40546e3c223b	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
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	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
SUCROSE
ALCOHOL
CARBOXYMETHYLCELLULOSE SODIUM
ANHYDROUS CITRIC ACID
GLYCERIN
WATER
SODIUM CITRATE
SODIUM HYDROXIDE
METHYLPARABEN
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42254-322	42254-322-60
50383-587

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
SUCROSE	C151H8M554	IACT
ALCOHOL	3K9958V90M	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	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 11 · 608 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAVITREAL	0.5 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		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
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAMUSCULAR		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / BUCCAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTERSTITIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 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
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 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
A064042-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL			1994-02-28

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	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1994-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064042-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL		1994-02-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064042-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064042-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064042-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064042-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064042-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064042-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064042-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064042-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064042-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064042-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064042-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064042-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064042-001	AA	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A064042-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064042-001	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.

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
8ce02e76-303c-4e06-a47e-0a7bbf46c3f2			8ce02e76-303c-4e06-a47e-0a7bbf46c3f2	2012-10-16	Adverse reactions	Exact identifier spl id: 8ce02e76-303c-4e06-a47e-0a7bbf46c3f2 spl set id: 8ce02e76-303c-4e06-a47e-0a7bbf46c3f2

Reported adverse events (FAERS/openFDA)#

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