Home NDC 52959-558 Nystatin and Triamcinolone Acetonide
Product NDC 52959-558
11-digit product format 529590558
Labeler code 52959
Product ID 52959-558_7f846eba-4489-4e7d-85fc-586ac9830380
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin and Triamcinolone Acetonide
Dosage form CREAM
Route TOPICAL
Labeler H.J. Harkins Company, Inc.
Application ANDA062364
Marketing category ANDA
Marketing start 1987-12-22
Marketing end 0000-00-00
Substance NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength 100000 [USP'U]/g; mg/g
Pharmacologic classes Polyene Antifungal [EPC],Polyenes [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062364-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062364-001 NYSTATIN AND TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% CREAM / TOPICAL AT RS 1987-12-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-558-01 Nystatin and Triamcinolone Acetonide 1 in 1 CARTON CREAM 1 2 52959-558-01 Nystatin and Triamcinolone Acetonide 30 g in 1 TUBE CREAM 30 2 52959-558-03 Nystatin and Triamcinolone Acetonide 15 g in 1 TUBE CREAM 15 2 52959-558-03 Nystatin and Triamcinolone Acetonide 1 in 1 CARTON CREAM 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 Triamcinolone Acetonide ACTIVE INGREDIENT F446C597KA NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 Triamcinolone ACTIVE MOIETY 1ZK20VI6TY NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 aluminum hydroxide INACTIVE INGREDIENT 5QB0T2IUN0 NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 sorbic acid INACTIVE INGREDIENT X045WJ989B NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 Sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-558 NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.] 2 Legacy NDC, 4 package rows 20120423_54af3d6a-d536-4df8-89ca-26acbe672400.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 52959-558-01 52959055801 1 in 1 CARTON Historical 52959-558-03 52959055803 15 g in 1 TUBE 15 g Historical