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 7 of 220 · 4,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
unii: 92RU3N3Y1O
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGPar Health USA, LLCde265fd1-bc22-4da1-aab5-b5fedd649c8b2026-08-24Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack20fa27ca-807a-4513-8af5-a835541d60d52026-08-24Adverse reactionsExact identifier
unii: F446C597KA
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016
unii: 92RU3N3Y1O
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
unii: 92RU3N3Y1O
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: T5L8T28FGP
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016

Reported adverse events (FAERS/openFDA)#

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