FDA.reportPublic FDA data

NDC 52565-014-08 - Sila III

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52565-014
Requested NDC
52565-014-08
Package NDCs from labels
52565-014-80, 52565-014-08, 52565-014-15, 52565-014-26
Manufacturer
PureTek Corporation
Effective date
2023-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sila III - PureTek CorporationPureTek Corporation2023-04-14HUMAN PRESCRIPTION DRUG LABEL
TriamazolePureTek Corporation | Teligent Pharma, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL
Trilociclo - PureTek Corporation | Perrigo New York IncPureTek Corporation | Perrigo New York Inc2020-12-15HUMAN PRESCRIPTION DRUG LABEL
Ellzia Pak - PureTek CorporationPureTek Corporation2020-11-11HUMAN PRESCRIPTION DRUG LABEL
Juulissa Pharmapak - PureTek CorporationPureTek Corporation2020-11-10HUMAN PRESCRIPTION DRUG LABEL
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%REMEDYREPACK INC.2019-08-15HUMAN PRESCRIPTION DRUG LABEL
Treziopak - PureTek CorporationPureTek Corporation2019-04-04HUMAN PRESCRIPTION DRUG LABEL
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%NuCare Pharmaceuticals,Inc.2017-07-17HUMAN PRESCRIPTION DRUG LABEL
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%Teligent Pharma, Inc.2016-05-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-014-152023-01-30C16284748780-1f386c64a-40e6-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%
52565-014-262023-01-30C16284748780-1f386c64a-40e6-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%
52565-014-802023-01-30C16284748780-1f386c64a-40e6-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-014-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT154
52565-014-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT14
52565-014-26Triamcinolone Acetonide1 in 1 CARTONOINTMENT14
52565-014-26Triamcinolone Acetonide454 g in 1 JAROINTMENT4544
52565-014-80Triamcinolone Acetonide80 g in 1 TUBEOINTMENT804
52565-014-80Triamcinolone Acetonide1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-014TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [TELIGENT PHARMA, INC.]4Legacy NDC, 6 package rows20211030_c25f35ab-c04c-496d-803f-2e497292faf8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-014-15GM - Gram52565-01422957237-45a9-4de1-953f-d9376b60b34112016-07-19
52565-014-26GM - Gram52565-0147893cd7e-6900-48a2-aad5-69e5f06b1f3712016-07-19
52565-014-80GM - Gram52565-0141892d50b-b513-44b4-ae9f-061fec1cb8ac12016-07-19

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 4 of 220 · 4,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
unii: ND2M416302
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
unii: ND2M416302
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
unii: ND2M416302
SurviveX Antiseptic WipesBZK ANTISEPTIC CLEANING WIPEChangzhou Maokang Medical Products Co., Ltd.5a82d9fb-dff8-1c89-e063-6394a90a32c92026-09-03WarningsExact identifier
unii: ND2M416302
Triamcinolone acetonideTRIAMCINOLONE ACETONIDERedpharm Drug5a79639b-eb66-e726-e063-6394a90aeb012026-09-02Adverse reactionsExact identifier
rxcui: 1085636
unii: F446C597KA
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
unii: 4T6H12BN9U
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
unii: ND2M416302
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
unii: ND2M416302
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
unii: ND2M416302
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
unii: ND2M416302
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
unii: 92RU3N3Y1O
Medline Alcohol Swabstick TriplesISOPROPYL ALCOHOLMedline Industries, LPe7759368-97c5-4b10-9bca-c197aeb62e462026-09-01WarningsExact identifier
unii: ND2M416302
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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