FDA.reportPublic FDA data

Nystatin and Triamcinolone Acetonide Ointment, USP

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-08-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:10:57

Label at a glance#

ProductNystatin and Triamcinolone Acetonide
Active ingredientNYSTATIN, TRIAMCINOLONE ACETONIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1447-1

Nystatin and Triamcinolone Acetonide Ointment, 15 gm

Rx only

Nystatin and Triamcinolone Acetonide Ointment
Nystatin and Triamcinolone Acetonide Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical OintmentPSN6
1053697nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD6
1053697nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical OintmentSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NYSTATIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TRIAMCINOLONE ACETONIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1447-1Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT16
70771-1447-1Nystatin and Triamcinolone Acetonide15 g in 1 TUBEOINTMENT156
70771-1447-2Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT16
70771-1447-2Nystatin and Triamcinolone Acetonide30 g in 1 TUBEOINTMENT306
70771-1447-3Nystatin and Triamcinolone Acetonide1 in 1 CARTONOINTMENT16
70771-1447-3Nystatin and Triamcinolone Acetonide60 g in 1 TUBEOINTMENT606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1447NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 6 package rows20240821_7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-144770771-1447-1, 70771-1447-2, 70771-1447-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
NYSTATINBDF1O1C72EACTIB
TRIAMCINOLONE ACETONIDEF446C597KAACTIB
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT

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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207764-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-0884e616aacf4f…
2026-08-18 06:07:402026-07A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICAL2018-11-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICAL2018-11-083f01610625f2…
2019-09-15 20:21 UTC2019-09A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICAL2018-11-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICAL2018-11-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207764-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%OINTMENT / TOPICALAT2018-11-08f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207764-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A207764-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207764-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207764-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207764-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207764-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207764-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207764-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207764-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207764-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207764-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207764-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207764-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207764-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207764-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207764-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207764-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207764-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207764-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207764-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207764-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207764-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A207764-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207764-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207764-001AT1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207764-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207764-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207764-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207764-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207764-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207764-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207764-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207764-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207764-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207764-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207764-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207764-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207764-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207764-001AT1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEZydus Lifesciences Limited7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f2024-08-16Exact identifier
ndc (package): 70771-1447-1
ndc (package): 70771-1447-3
ndc (package): 70771-1447-2
ndc (product): 70771-1447
ndc11 (package): 70771144702
ndc11 (package): 70771144701
ndc11 (package): 70771144703
spl id: 349e5bb9-e74a-45f6-8d4f-75f0b1ad8d3f
spl set id: 7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f

Reported adverse events (FAERS/openFDA)#

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