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 9 of 220 · 4,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
unii: T5L8T28FGP
Carbo ChamomillaCARBO CHAMOMILLAUriel Pharmacy Inc.6bc88bd3-ffe9-46d7-e053-2a91aa0acf792026-08-14WarningsExact identifier
unii: C5529G5JPQ
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
CHILDRENS TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLC9e50af36-59f1-4f08-a0d7-7566f0a110342026-08-13WarningsExact identifier
unii: F446C597KA
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLCa74eff58-bce4-4785-b583-3e474f8250702026-08-13WarningsExact identifier
unii: F446C597KA
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
unii: T5L8T28FGP
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
unii: ND2M416302
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 68Y4CF58BV
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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