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 2 of 25 · 481 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
unii: T5L8T28FGP
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack3a85b137-7ef0-4b1d-8590-69c139355a132026-08-10Adverse reactionsExact identifier
unii: F446C597KA
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackb2ba93bc-3775-466b-8daf-4ffa3edc9c002026-08-10Adverse reactionsExact identifier
unii: F446C597KA
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackf152b99c-5363-40f9-9fad-c3e36b7c3df12026-08-10Adverse reactionsExact identifier
unii: F446C597KA
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Nasal AllergyTRIAMCINOLONE ACETONIDEHyVee Inc5ad719a7-3872-4d0c-93e6-603e4653ec422026-08-05WarningsExact identifier
unii: F446C597KA
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc., USAdc886fb9-535c-4fd8-959a-f590a3bf36682026-08-04Adverse reactionsExact identifier
unii: F446C597KA
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
unii: T5L8T28FGP
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.3051aa96-b12a-4a1d-947d-9b769bca8dc82026-07-31Adverse reactionsExact identifier
unii: F446C597KA
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
unii: T5L8T28FGP
KENALOG-10TRIAMCINOLONE ACETONIDEA-S Medication Solutions653ec195-0966-478d-be47-6b1ff158e1112026-07-30Warnings, Adverse reactionsExact identifier
unii: F446C597KA
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: K679OBS311
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.3d495acf-8085-4aaa-8fc5-594b88c25c212026-07-13Adverse reactionsExact identifier
unii: F446C597KA
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLC20c1234b-6749-422d-9420-9d5a98f5f30a2026-07-13Adverse reactionsExact identifier
unii: F446C597KA
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCccca8660-124e-4220-8d87-4b9aeecbda7d2026-07-13Adverse reactionsExact identifier
unii: F446C597KA
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
unii: T5L8T28FGP
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
unii: T5L8T28FGP
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.db87426f-124c-4ea9-bb15-fc3a0da10a4e2026-07-07Adverse reactionsExact identifier
unii: F446C597KA
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.6a31a0c3-2b6e-40e3-b5ea-5c665afd35672026-07-06Adverse reactionsExact identifier
unii: F446C597KA
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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