NYSTATIN CREAM USP

Manufacturer: Proficient Rx LP
Effective date: 2021-01-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 22:56:33

Label at a glance#

ProductNystatin

Active ingredientNYSTATIN

Label structure10 sections

Indications and uses

Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

Dosage and administration

Nystatin Cream USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions however are best treated with nystatin topical powder. The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

(100,000 units/g)

Rx Only

DESCRIPTION

DESCRIPTION SECTION

EACH GRAM OF NYSTATIN CREAM USP CONTAINS: 100,000 units in an aqueous cream base of aluminum hydroxide gel, cetearyl alcohol (and) ceteareth-20, citric acid, glyceryl stearate, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitol solution, titanium dioxide and white petrolatum.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably 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 a polyene antibiotic of undetermined structural formula that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida (Monilia) albicans and other Candida species. It exhibits no appreciable activity against bacteria.

Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.

PRECAUTIONS

PRECAUTIONS SECTION

Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration.

If irritation on topical application should occur, discontinue medication.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

HOW SUPPLIED

HOW SUPPLIED SECTION

Nystatin Cream USP 100,000 units/g

15 g tube (0.53 oz)

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid exposure to excessive heat, 40°C (104°F).

Manufactured by:

Actavis Mid Atlantic LLC

1877 Kawai Road

Lincolnton, NC 28092 USA

FORM NO. 0163

Rev. 1/06

VC2751

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-422	NYSTATIN CREAM [PROFICIENT RX LP]	3	Legacy NDC	20210115_b9d5a099-00ef-40b6-90a4-254f2be551d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0163-15	GM - Gram	0472-0163	b87845c2-79fd-45a4-a767-33714f3e7b74	1	2013-02-13
0472-0163-30	GM - Gram	0472-0163	eed2ca4f-24d7-4c54-a17f-23fb36cc444b	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
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Nystatin
ALUMINUM HYDROXIDE
CETOSTEARYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
POLYOXYL 40 STEARATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE, UNSPECIFIED FORM
SORBIC ACID
SORBITOL
TITANIUM DIOXIDE
PETROLATUM
METHYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63187-422	63187-422-15
0472-0163

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NYSTATIN	BDF1O1C72E	ACTIB
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
POLYOXYL 40 STEARATE	13A4J4NH9I	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
SORBIC ACID	X045WJ989B	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PETROLATUM	4T6H12BN9U	IACT
METHYLPARABEN	A2I8C7HI9T	IACT

Source Document#

Source XML · Source PDF

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 9 · 484 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	TABLET / ORAL	8.48 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET / ORAL		10 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	AEROSOL, FOAM / TOPICAL	2.83 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates

Orange Book application contexts#

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

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

Source provenance: Browse the complete Orange Book source catalog · 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
A062949-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT		1988-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062949-001	AT

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062949-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	1988-06-13	`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	A062949-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062949-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062949-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062949-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062949-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062949-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062949-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062949-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062949-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062949-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062949-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062949-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062949-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062949-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062949-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062949-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062949-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062949-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062949-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062949-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062949-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062949-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062949-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062949-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062949-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062949-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062949-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062949-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062949-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062949-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062949-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062949-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062949-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062949-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062949-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062949-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062949-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062949-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062949-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062949-001	AT	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0c514a32-8f16-48e6-a852-5dcd79583161			b9d5a099-00ef-40b6-90a4-254f2be551d5	2025-06-01	Adverse reactions	Exact identifier spl set id: b9d5a099-00ef-40b6-90a4-254f2be551d5

Reported adverse events (FAERS/openFDA)#

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