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 3 of 220 · 4,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
unii: ND2M416302
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
unii: ND2M416302
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
unii: ND2M416302
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact identifier
unii: ND2M416302
MeijerISOPROPYL ALCOHOLMeijer Distribution Incca008d84-cf51-3703-e053-2a95a90a9bf12026-09-04WarningsExact identifier
unii: ND2M416302
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
unii: ND2M416302
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
unii: ND2M416302
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016

Reported adverse events (FAERS/openFDA)#

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