FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-558IInactivated by FDA2026-07-31
excluded packagepackage52959-55852959-558-01IInactivated by FDA2026-07-31
excluded packagepackage52959-55852959-558-03IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062364-001AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A062364-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALATRS1987-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062364-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.ea065dd4-dfd3-46a2-92de-8a0b49cb94552026-01-14Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd2025-08-28Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.2fd97fc5-cae5-43dd-a3c7-c9a03876153e2025-07-07Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.90a58c0e-85cf-3aad-e053-2a95a90a316a2024-06-19Adverse reactionsExact identifier
application applno (ANDA): 062364
application number: ANDA062364

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-558-012020-01-31C16284748780-19d75b9d1-0ab0-f424-e053-dadaa90a57ceNystatin and Triamcinolone Acetonide Cream, USP
52959-558-032020-01-31C16284748780-19d75b9d1-0ab0-f424-e053-dadaa90a57ceNystatin and Triamcinolone Acetonide Cream, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-558-01Nystatin and Triamcinolone Acetonide1 in 1 CARTONCREAM12
52959-558-01Nystatin and Triamcinolone Acetonide30 g in 1 TUBECREAM302
52959-558-03Nystatin and Triamcinolone Acetonide15 g in 1 TUBECREAM152
52959-558-03Nystatin and Triamcinolone Acetonide1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-558-01GM - Gram52959-558925483e7-52f4-43da-ab79-c7694306f16212012-07-24
52959-558-03GM - Gram52959-55821e78845-2ec4-420c-913c-e0644f5853c612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KANYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
TriamcinoloneACTIVE MOIETY1ZK20VI6TYNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
aluminum hydroxideINACTIVE INGREDIENT5QB0T2IUN0NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
sorbic acidINACTIVE INGREDIENTX045WJ989BNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
SorbitolINACTIVE INGREDIENT506T60A25RNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-558NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 4 package rows20120423_54af3d6a-d536-4df8-89ca-26acbe672400.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSN54af3d6a-d536-4df8-89ca-26acbe6724002
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCD54af3d6a-d536-4df8-89ca-26acbe6724002
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSY54af3d6a-d536-4df8-89ca-26acbe6724002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-558-01529590558011 in 1 CARTONHistorical
52959-558-035295905580315 g in 1 TUBE15 gHistorical