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 4 of 25 · 481 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions6d565a2c-d145-425a-a87d-6d07a90ad2fe2026-04-27Adverse reactionsExact identifier
unii: F446C597KA
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: K679OBS311
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
unii: T5L8T28FGP
allergy reliefTRIAMCINOLONE ACETONIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd2c36b17-d5ed-4f91-b3cc-15900e6b341d2026-04-20WarningsExact identifier
unii: F446C597KA
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
unii: T5L8T28FGP
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.809c8ef7-6313-412e-82c7-adaa824bb5992026-04-15Adverse reactionsExact identifier
unii: F446C597KA
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack3fc24a96-91b0-46bd-bf16-b3d5739e9c072026-04-14Adverse reactionsExact identifier
unii: F446C597KA
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
unii: 89NA02M4RX
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEDirect_Rx4d29394d-4725-f912-e063-6294a90a062c2026-04-08Adverse reactionsExact identifier
unii: F446C597KA
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack6658728a-99d7-48c3-83d6-4e40c59c9b472026-04-07Adverse reactionsExact identifier
unii: F446C597KA
Allergy NasalTRIAMCINOLONE ACETONIDEWalgreen Companya33aa2f3-9e9e-4408-b671-508c79a29c062026-04-07WarningsExact identifier
unii: F446C597KA
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmceuticals,Inc.4e94fde1-ea31-e333-e063-6294a90a51072026-04-03Adverse reactionsExact identifier
unii: F446C597KA
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions10cf5e2f-0e9f-4fc0-af4a-3be46a4af4752026-04-02Adverse reactionsExact identifier
unii: F446C597KA
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLC8d11aee3-b66e-439b-9188-7d91219a59cf2026-04-01Warnings, Adverse reactionsExact identifier
unii: F446C597KA
TRIESENCETRIAMCINOLONE ACETONIDENovartis Pharmaceuticals Corporation22692d92-1359-9252-e063-6394a90ab6692026-04-01Warnings, Adverse reactionsExact identifier
unii: F446C597KA
Sootheez Birthday CakePECTINPrimrose Candy Co.4e5d8234-0521-0c8a-e063-6294a90ae62d2026-03-31WarningsExact identifier
unii: 89NA02M4RX
Sootheez Watermelon MintPECTINPrimrose Candy Co.4e5e4342-4647-ef25-e063-6394a90a1d132026-03-31WarningsExact identifier
unii: 89NA02M4RX
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEDirect_rx4e400049-c763-56f7-e063-6294a90a6fd72026-03-30Adverse reactionsExact identifier
unii: F446C597KA
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
unii: T5L8T28FGP
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack0844a8f0-116d-40f6-8462-cccd6bcefc8a2026-03-27Adverse reactionsExact identifier
unii: F446C597KA

Reported adverse events (FAERS/openFDA)#

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