NYSTATIN OINTMENT USP

Manufacturer: Rebel Distributors Corp | PSS World Medical, Inc. | STAT RX USA LLC | Dispensing Solutions, Inc. | SCRIPT PAK | Keltman Pharmaceuticals, Inc. | Rebel Distirbutors Corp.
Effective date: 2012-08-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:16:42

Label at a glance#

ProductNystatin

Active ingredientnystatin

Label structure10 sections

Indications and uses

Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia] albicans and other Candida species.

Dosage and administration

Nystatin Ointment should be applied liberally to 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. This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

R_x only

DESCRIPTION

DESCRIPTION SECTION

Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:

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 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 Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Nystatin Ointment 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 non-toxic 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

This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

HOW SUPPLIED

HOW SUPPLIED SECTION

Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:

NDC 42254-284-15 15 gram tube

Store at controlled room temperature 15°- 30°C (59°-86°F).

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747
I20715H
R08/11
#21

Repackaged by:
REBEL DISTRIBUTORS CORP.
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nystatin 100,000 Units/gm

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	1
884308	nystatin 100 UNT/MG Topical Ointment	SCD	1
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NYSTATIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-284-15	2019-09-24	C162847	48780-1	9350213a-3d49-c013-e053-90daa90a1393	NYSTATIN OINTMENT USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-284-15	Nystatin	15 g in 1 TUBE	OINTMENT	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-284	NYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20130329_da4cd3fc-906d-4468-b7f9-c20f085c95ed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-284-15	GM - Gram	42254-284	6c62d2f1-8e50-49f6-bf24-ab4c21f6e627	1	2013-04-01
0168-0007-15	GM - Gram	0168-0007	52751ca1-1910-4597-8fa6-faa22e9bacab	1	2012-07-24
0168-0007-30	GM - Gram	0168-0007	e865dc45-e1a9-4f36-b7cc-2aa04b9958ec	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
nystatin	ACTIVE INGREDIENT	BDF1O1C72E	1
nystatin	ACTIVE MOIETY	BDF1O1C72E	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Nystatin
HIGH DENSITY POLYETHYLENE
Mineral Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42254-284	42254-284-15
0168-0007

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
nystatin	BDF1O1C72E	ACTIB
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
Mineral Oil	T5L8T28FGP	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 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Mineral Oil	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	GEL / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE, EXTENDED RELEASE / ORAL	4.53 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, COATED / ORAL	25 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET / ORAL	50 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TAPE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SYSTEM / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CREAM / TOPICAL	54.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, EXTENDED RELEASE / ORAL	0.64 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / TOPICAL	94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	JELLY / VAGINAL	42.6 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE / ORAL	10 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	FILM, EXTENDED RELEASE / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 18 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
A062124-002	NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062124-002	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 · 43 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
2026-09-14 22:38:34	2026-08	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062124-002	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	RS	1982-09-23	`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	A062124-002	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062124-002	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062124-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062124-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062124-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062124-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062124-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062124-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062124-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062124-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062124-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062124-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062124-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062124-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062124-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062124-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062124-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062124-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062124-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062124-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062124-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062124-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062124-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062124-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062124-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062124-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062124-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062124-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062124-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062124-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062124-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062124-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062124-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062124-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062124-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062124-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062124-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062124-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062124-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062124-002	AT	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
da4cd3fc-906d-4468-b7f9-c20f085c95ed			da4cd3fc-906d-4468-b7f9-c20f085c95ed	2012-08-28	Adverse reactions	Exact identifier spl id: da4cd3fc-906d-4468-b7f9-c20f085c95ed spl set id: da4cd3fc-906d-4468-b7f9-c20f085c95ed

Reported adverse events (FAERS/openFDA)#

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