Nystatin Tablets USP Rx only

Manufacturer: AvKARE
Effective date: 2025-09-18
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 21:43:35

Label at a glance#

ProductNystatin

Active ingredientNYSTATIN

Label structure10 sections

Indications and uses

Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

Dosage and administration

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

Contacts and useful links#

PhoneLabel contact1-855-361-3993

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

Structural formula for nystatin

C ₄₇H ₇₅NO ₁₇ M.W. 926.13

Nystatin tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Pharmacokinetics

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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 tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Nystatin Tablets are contraindicated in patients with a history of hypersensitivity to any of their 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

TERATOGENIC EFFECTS SECTION

Pregnancy Category C

SPL UNCLASSIFIED SECTION

Animal reproduction 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.

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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

Gastrointestinal

SPL UNCLASSIFIED SECTION

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

SPL UNCLASSIFIED SECTION

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

SPL UNCLASSIFIED SECTION

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or 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 of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Nystatin Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 90 tablets (NDC 42291-651-90).

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured For:
AvKARE

Pulaski, TN 38478

Mfg. Rev. 11/22

AV Rev. 09/25(M)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312059	nystatin 500,000 UNT Oral Tablet	PSN	7
312059	nystatin 500000 UNT Oral Tablet	SCD	7
312059	nystatin 500,000 UNT Oral Tablet	SY	7

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
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-651-90	Nystatin	90 in 1 BOTTLE	TABLET, FILM COATED	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-651-90	EA - Each	42291-651	90c1e072-2372-47e5-a770-f3481dfd6f3b	1	2014-05-02
0093-0983-01	EA - Each	0093-0983	a85e584d-5dd6-4f15-b3c0-733ec7d4b504	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	1
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Nystatin
STARCH, CORN
POVIDONE K29/32
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
WATER
ISOPROPYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42291-651	42291-651-90
0093-0983

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
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE K29/32	390RMW2PEQ	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
WATER	059QF0KO0R	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
NYSTATIN	BDF1O1C72E	ACTIB

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 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 3 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 3 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 44.

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
A062506-001	NYSTATIN	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062506-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062506-001	NYSTATIN	500,000 UNITS	TABLET / ORAL	AA	RS	1984-01-16	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A062506-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062506-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062506-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062506-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062506-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062506-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062506-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062506-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062506-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062506-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062506-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062506-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062506-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062506-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062506-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062506-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062506-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062506-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062506-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062506-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062506-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062506-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062506-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062506-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062506-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062506-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062506-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062506-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062506-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062506-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062506-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062506-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062506-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062506-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062506-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062506-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062506-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062506-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062506-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062506-001	AA	1	`3a93d1ddd44b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nystatin	NYSTATIN	AvKARE	8fd35f97-5405-2160-ca0f-35034ecd5a92	2025-09-18	Adverse reactions	Exact identifier ndc (package): 42291-651-90 ndc (product): 42291-651 ndc11 (package): 42291065190 spl id: 3f165da9-403f-6f69-e063-6294a90a45bc spl set id: 8fd35f97-5405-2160-ca0f-35034ecd5a92
Nystatin	NYSTATIN	Teva Pharmaceuticals USA, Inc.	f03b294d-10cd-4bba-92c8-42ae9b110cd0	2022-11-01	Adverse reactions	Exact identifier ndc (product): 0093-0983

Reported adverse events (FAERS/openFDA)#

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