NYSTATIN CREAM USP

Manufacturer: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | MIDI Labs, Inc
Effective date: 2020-02-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-01 23:39:54

Label at a glance#

Productnystatin

Active ingredientnystatin

Label structure11 sections

Indications and uses

Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage and administration

Adults and Pediatric Patients (Neonates and Older) : Apply liberally to affected area twice daily or as indicated until healing is complete.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FOR TOPICAL USE ONLY.

Rx only

NOT FOR OPHTHALMIC USE.

DESCRIPTION:

DESCRIPTION SECTION

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula:

Molecular Weight 926.13

Molecular Formula C₄₇H₇₅NO₁₇

Nystatin cream is for dermatologic use.

Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, vanishing cream base containing Polysorbate 60, Aluminum Hydroxide Compressed Gel, Titanium Dioxide, Glyceryl Monostearate, Polyethylene Glycol 400 Monostearate, Simethicone Emulsion, Sorbic Acid, Propylene Glycol, Ethylenediamine, Polyoxyethylene Fatty Alcohol Ether, Sorbitol Solution, Methylparaben, Propylparaben, Hydrochloric Acid, White Petrolatum, and Purified Water.

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

PHARMACOKINETICS SECTION

Pharmacokinetics: Nystatin is not absorbed from intact skin or mucous membrane.

MICROBIOLOGY SECTION

Microbiology: Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS:

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

INFORMATION FOR THE PATIENT: Patients using this medication should receive the following information and instructions:

1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.

2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.

3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

LABORATORY TESTS SECTION

Laboratory Tests: If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or the effects on male or female fertility.

PREGNANCY SECTION

TERATOGENIC EFFECTS SECTION

SPL UNCLASSIFIED SECTION

Pregnancy: Teratogenic Effects: Category C: Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

NURSING MOTHERS SECTION

Nursing Mothers: It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

PEDIATRIC USE SECTION

Pediatric Use: Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION.)

GERIATRIC USE SECTION

Geriatric Use: Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.]

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS : General.)

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected area twice daily or as indicated until healing is complete.

HOW SUPPLIED:

HOW SUPPLIED SECTION

Nystatin Cream USP is available as follows:

NDC 0168-0054-15 15 gram tube
NDC 0168-0054-30 30 gram tube

Each tube provides 100,000 USP Nystatin Units per gram.

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

Avoid freezing.

E. FOUGERA & CO.
A division of
Fougera
PHARMACEUTICALS INC.
Melville, New York 11747

I25415G
R07/13
#61

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15G CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0054-15

FOUGERA^®

NYSTATIN CREAM USP
100,000 USP Nystatin Units Per Gram

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0054-15

Rx only

FOUGERA^®

NYSTATIN CREAM USP
100,000 USP Nystatin Units Per Gram

WARNING: Keep this and all
drugs out of reach of children.

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

NET WT 15 grams

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0054-15	GM - Gram	0168-0054	26117686-e6fd-468d-8bb1-b5c7e40c32eb	1	2013-09-04
0168-0054-30	GM - Gram	0168-0054	0f9a7c43-5f21-40ff-b45b-38c62802e73c	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
nystatin	ACTIVE INGREDIENT	BDF1O1C72E	6
nystatin	ACTIVE MOIETY	BDF1O1C72E	6
Algeldrate	INACTIVE INGREDIENT	03J11K103C	6
Ethylenediamine	INACTIVE INGREDIENT	60V9STC53F	6
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	6
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	6
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	6
PEG-8 Stearate	INACTIVE INGREDIENT	2P9L47VI5E	6
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	6
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	6
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	6
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	6
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	6
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	6
Sorbitol	INACTIVE INGREDIENT	506T60A25R	6
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	6
Water	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

nystatin
Polysorbate 60
Algeldrate
Titanium Dioxide
Glyceryl Monostearate
PEG-8 Stearate
Silicon Dioxide
Sorbic Acid
Propylene Glycol
Ethylenediamine
Sorbitol
Methylparaben
Propylparaben
Hydrochloric Acid
Petrolatum
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0168-0054	0168-0054-15, 0168-0054-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
nystatin	BDF1O1C72E	ACTIB
Polysorbate 60	CAL22UVI4M	IACT
Algeldrate	03J11K103C	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
PEG-8 Stearate	2P9L47VI5E	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Sorbic Acid	X045WJ989B	IACT
Propylene Glycol	6DC9Q167V3	IACT
Ethylenediamine	60V9STC53F	IACT
Sorbitol	506T60A25R	IACT
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	IACT
Hydrochloric Acid	QTT17582CB	IACT
Petrolatum	4T6H12BN9U	IACT
Water	059QF0KO0R	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 10 · 590 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	5 mg		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Algeldrate	ALGELDRATE	03J11K103C	TABLET, FILM COATED / ORAL	183.75 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 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
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	1.5 %w/w		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PEG-8 Stearate	PEG-8 MONOSTEARATE	2P9L47VI5E	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION / NASAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / IONTOPHORESIS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 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
A062129-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062129-001	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	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062129-001	NYSTATIN	100,000 UNITS/GM	CREAM / TOPICAL	AT	Approved before 1982	`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	A062129-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062129-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062129-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062129-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062129-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062129-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062129-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062129-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062129-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062129-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062129-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062129-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062129-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062129-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062129-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062129-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062129-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062129-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062129-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062129-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062129-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062129-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062129-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062129-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062129-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062129-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062129-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062129-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062129-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062129-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062129-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062129-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062129-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062129-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062129-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062129-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062129-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062129-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062129-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062129-001	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
e82d5a8f-5104-4e54-8cdb-3d4a89333886			c9e28323-21fa-4547-b70c-27dc13a5bd7e	2020-02-27	Adverse reactions	Exact identifier spl set id: c9e28323-21fa-4547-b70c-27dc13a5bd7e

Reported adverse events (FAERS/openFDA)#

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