Nystatin Ointment USP For Topical Use Only Not for Ophthalmic Use

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:10:57

Label at a glance#

ProductNystatin

Active ingredientNYSTATIN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1357-1

Nystatin Ointment USP, 15 g

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
884308	nystatin 100,000 UNT/GM Topical Ointment	PSN	5
884308	nystatin 100 UNT/MG Topical Ointment	SCD	5
884308	nystatin 100,000 UNT/GM Topical Ointment	SY	5

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
70771-1357-1	Nystatin	15 g in 1 TUBE	OINTMENT	15		5
70771-1357-2	Nystatin	30 g in 1 TUBE	OINTMENT	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1357	NYSTATIN OINTMENT [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20240821_6aa2f67e-9636-45e5-be1b-83e7ab86e436.zip

Products#

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

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

Nystatin
MINERAL OIL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1357	70771-1357-1, 70771-1357-2

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
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML

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
A207767-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT		2018-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207767-001	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	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207767-001	NYSTATIN	100,000 UNITS/GM	OINTMENT / TOPICAL	AT	2018-05-25	`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	A207767-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207767-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207767-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207767-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207767-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207767-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207767-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207767-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207767-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207767-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207767-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207767-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207767-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207767-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207767-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207767-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207767-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207767-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207767-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207767-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207767-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207767-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207767-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207767-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207767-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207767-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207767-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207767-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207767-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207767-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207767-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207767-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207767-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207767-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207767-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207767-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207767-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207767-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207767-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207767-001	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
Nystatin	NYSTATIN	Zydus Lifesciences Limited	6aa2f67e-9636-45e5-be1b-83e7ab86e436	2024-08-16		Exact identifier ndc (package): 70771-1357-1 ndc (package): 70771-1357-2 ndc (product): 70771-1357 ndc11 (package): 70771135701 ndc11 (package): 70771135702 spl id: f94a3196-9f89-4b93-8b26-bf811b9bbc3f spl set id: 6aa2f67e-9636-45e5-be1b-83e7ab86e436

Reported adverse events (FAERS/openFDA)#

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