Nystatin Oral Suspension, USP

Manufacturer: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | Fougera Pharmaceuticals Inc.
Effective date: 2012-07-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:46:44

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 (approximately 1/2 teaspoon)(200,000 units) four times daily 1 mL (approximately 1/4/ teaspoon) (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 (approximately 1 teaspoon)(400,000 to 600,000 units) four times daily (one...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

DESCRIPTION SECTION

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. The structural formula is:

Molecular Formula: C₄₇ H₇₅ NO₁₇ Molecular Weight: 926.13

Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol USP (not more than 1% by volume), mint blend flavoring, dibasic sodium phosphate USP, glycerin USP, purified water USP, colloidal silicon dioxide, sucrose NF (50%), methylparaben NF (0.12%) and propylparaben NF (0.03%) as preservatives.

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.

TERATOGENIC EFFECTS SECTION

Pregnancy: Teratogenic Effects–Pregnancy Category C. 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.

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

SPL UNCLASSIFIED SECTION

INFANTS: 2 mL (approximately 1/2 teaspoon)(200,000 units) four times daily 1 mL (approximately 1/4/ teaspoon) (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.

SPL UNCLASSIFIED SECTION

CHILDREN AND ADULTS: 4 - 6 mL (approximately 1 teaspoon)(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 USP Nystatin Units per mL) is available as a mint-flavored, light yellow, ready-to-use suspension in the following sizes:

NDC 0168-0037-60       60 mL bottle (with a calibrated dosing cup)
NDC 0168-0037-61       60 mL bottle (with a calibrated dropper)
NDC 0168-0037-74       1 Pint bottle

Shake well before using. Wash cup before and after each use.
Before dispensing, replace cap with safety cap dropper.

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

WARNING: Keep out of reach of children.

This product sealed for your protection. If the seal is missing or broken return to place of purchase.

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

I237C/IF237E
R11/07
#276

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60ML CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0037-60

FOUGERA^®

NYSTATIN ORAL

SUSPENSION USP

100,000 USP Nystatin Units per mL

Rx only

60mL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60ML CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0037-60

FOUGERA^®

NYSTATIN ORAL

SUSPENSION USP

100,000 USP

Nystatin Units per mL

Rx only

60mL

with Dose

Measuring Cup

Shake well before using.

Wash cup before

and after use.

WARNING: Keep out

of reach of children.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60ML CARTON

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0168-0037-60	2024-07-12	C162847	48780-1	9d75b9cf-e855-f424-e053-dadaa90a57ce	Nystatin Oral Suspension, USP
0168-0037-60	2020-01-31	C162847	48780-1	9d75b9cf-e855-f424-e053-dadaa90a57ce	Nystatin Oral Suspension, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
nystatin	ACTIVE INGREDIENT	BDF1O1C72E	2
nystatin	ACTIVE MOIETY	BDF1O1C72E	2
alcohol	INACTIVE INGREDIENT	3K9958V90M	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	2
sucrose	INACTIVE INGREDIENT	C151H8M554	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

nystatin
alcohol
sodium phosphate, dibasic
glycerin
water
silicon dioxide
sucrose
methylparaben
propylparaben

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0168-0037	0168-0037-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
nystatin	BDF1O1C72E	ACTIB
alcohol	3K9958V90M	IACT
sodium phosphate, dibasic	GR686LBA74	IACT
glycerin	PDC6A3C0OX	IACT
water	059QF0KO0R	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
sucrose	C151H8M554	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 7 · 392 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 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
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	TABLET, EXTENDED RELEASE / ORAL		143 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 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	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 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
A062517-001	NYSTATIN	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA		1984-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062517-001	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	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062517-001	NYSTATIN	100,000 UNITS/ML	SUSPENSION / ORAL	AA	1984-06-07	`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	A062517-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062517-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062517-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062517-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062517-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062517-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062517-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062517-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062517-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062517-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062517-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062517-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062517-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062517-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062517-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062517-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062517-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062517-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062517-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062517-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062517-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062517-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062517-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062517-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062517-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062517-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062517-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062517-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062517-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062517-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062517-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062517-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062517-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062517-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062517-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062517-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062517-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062517-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062517-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062517-001	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
375e3633-a3c5-49ce-9af5-8d4e23fd3d8f			855277ef-d6ad-4582-a289-c8c739bf675b	2021-08-12	Adverse reactions	Exact identifier spl set id: 855277ef-d6ad-4582-a289-c8c739bf675b

Reported adverse events (FAERS/openFDA)#

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