FDA.reportPublic FDA data

NDC 51672-1335-08 - Oralone

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
51672-1335
Requested NDC
51672-1335-08
Package NDCs from labels
51672-1335-5, 51672-1335-8, 51672-1335-08
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oralone ® (Triamcinolone Acetonide Dental Paste USP, 0.1%)Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1335-5Oralone1 in 1 CARTONPASTE14
51672-1335-5Oralone5 g in 1 TUBEPASTE54
51672-1335-8Oralone7.5 g in 1 TUBEPASTE7.54
51672-1335-8Oralone1 in 1 CARTONPASTE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1335ORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20190208_ac1e2116-795e-4c20-974d-11fa07cf0fa7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1335-5GM - Gram51672-133526bf845e-7f60-4ae6-b943-a21c66e7017312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KAORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
TriamcinoloneACTIVE MOIETY1ZK20VI6TYORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
GelatinINACTIVE INGREDIENT2G86QN327LORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
pectinINACTIVE INGREDIENT89NA02M4RXORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1AORALONE (TRIAMCINOLONE ACETONIDE) PASTE [TARO PHARMACEUTICALS U.S.A., INC.]2

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 25 · 481 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCa5cc640f-c72d-49fa-b970-906c9ffd86292026-01-28Adverse reactionsExact identifier
unii: F446C597KA
triamcinolone acetonideTRIAMCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC92a1ded0-8e1a-4994-9c8a-89e84fc85c942026-01-28Adverse reactionsExact identifier
unii: F446C597KA
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
unii: K679OBS311
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
unii: K679OBS311
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEASCLEMED USA INC.b909659e-8dd5-4652-89f4-c4d6b741a8552026-01-23Warnings, Adverse reactionsExact identifier
unii: F446C597KA
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
unii: T5L8T28FGP
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.5439cd3c-da8d-3b96-e054-00144ff8d46c2026-01-21Adverse reactionsExact identifier
unii: F446C597KA
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.037efc03-22ab-45eb-9b0e-b125e4b5eb992026-01-20Adverse reactionsExact identifier
unii: F446C597KA
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLCcab0573d-e760-4ff5-a69f-0ce06cfdb97a2026-01-19Warnings, Adverse reactionsExact identifier
unii: F446C597KA
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.60973042-077c-4265-988c-ad381f5603332026-01-19Adverse reactionsExact identifier
unii: F446C597KA
Walgreens Wild Cherry Throat DropsPECTINWalgreens4885eca3-c1e9-8350-e063-6394a90ac2902026-01-16WarningsExact identifier
unii: 89NA02M4RX
Family Care Single Use Lubricant Eye Drop 0.4mL 5ctCARBOXYMETHYLCELLULOSE SODIUMUnited Exchange Corp48879feb-b5ae-a9e6-e063-6394a90a03b22026-01-16WarningsExact identifier
unii: K679OBS311
Family Care Single Use Lubricant Eye Drop 0.4mL 30ctCARBOXYMETHYL CELLULOSE 0.5%United Exchange Corp488b3363-8d06-7dcc-e063-6294a90ab44c2026-01-16WarningsExact identifier
unii: K679OBS311
Nystatin and triamcinolone acetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.c529567b-7061-4389-8c7a-20ef2b22c5912026-01-16Adverse reactionsExact identifier
unii: F446C597KA
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
unii: T5L8T28FGP
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
unii: T5L8T28FGP
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
unii: T5L8T28FGP
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
unii: T5L8T28FGP
Nasacort Allergy 24HRTRIAMCINOLONE ACETONIDEChattem, Inc.4bff57a5-cce0-401c-a0fe-23c65c1b7ddc2026-01-14WarningsExact identifier
unii: F446C597KA
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions33793dfe-1214-4e0f-904c-771711ecb1252026-01-14Adverse reactionsExact identifier
unii: F446C597KA

Reported adverse events (FAERS/openFDA)#

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