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 9 of 24 · 471 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCVS Pharmacy, Inc.8eef499d-c60e-9468-e053-2995a90a87142025-12-30WarningsExact identifier
unii: K679OBS311
CVS Lubricant Eye Drops 30 ctCARBOXYMETHYLCELLULOSE SODUIMCVS Pharmacy, Inc.8dbca077-c989-767a-e053-2995a90a7cf52025-12-30WarningsExact identifier
unii: K679OBS311
TopCare Health Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTopcare Associates LLCe8e9dfe5-3540-a4df-e053-2a95a90aaf982025-12-30WarningsExact identifier
unii: K679OBS311
Meijer Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMMeijer Distribution, Inc.b245f99f-785a-efdc-e053-2995a90a49112025-12-30WarningsExact identifier
unii: K679OBS311
Leader Lubricant Eye Drops Soothing ReliefCARBOXYMETHYLCELLULOSE SODIUMLEADER/Cardinal Health 110, Inc.218629d4-2704-a503-e063-6294a90a39532025-12-30WarningsExact identifier
unii: K679OBS311
Foster and Thrive Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMStrategic Sourcing Services LLCfb85ebc0-1570-972b-e053-6294a90a3dc42025-12-30WarningsExact identifier
unii: K679OBS311
Equate Optimal Hydration Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart, Inc.151b9723-5d5e-ac2b-e063-6294a90af0732025-12-30WarningsExact identifier
unii: K679OBS311
Equate Moisturizing Comfort Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart Inc.152028bd-0429-720a-e063-6294a90a14652025-12-30WarningsExact identifier
unii: K679OBS311
QUALITY CHOICE Cough Drops Creamy StrawberryCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23085717-b2ee-175c-e063-6394a90a7f542025-12-29WarningsExact identifier
unii: 89NA02M4RX
MGC HealthCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f42644-045b-c4b3-e063-6294a90a48fd2025-12-29WarningsExact identifier
unii: 89NA02M4RX
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a92ecc-6a9c-b569-e063-6394a90a8bcb2025-12-29WarningsExact identifier
unii: 89NA02M4RX
Creamy Strawberry Flavor Cough DropCREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2749b83a-ea4f-d8ca-e063-6394a90a69b72025-12-26WarningsExact identifier
unii: 89NA02M4RX
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
unii: K679OBS311
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim46854996-a0b9-46b4-e063-6294a90aa4332025-12-22WarningsExact identifier
unii: K679OBS311
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
unii: 89NA02M4RX
MGC HealthCOUGH DROPS CREAMY STRAWBERRYMedical Group Care LLC043a5e11-30c3-44cd-e063-6394a90a318b2025-12-22WarningsExact identifier
unii: 89NA02M4RX
MGC Health Throat Soothing Drops Creamy StrawberryPECTINMedical Group Care LLC3fa195b5-0712-aada-e063-6394a90a90692025-12-22WarningsExact identifier
unii: 89NA02M4RX
QUALITY CHOICE Cough Drops Creamy StrawberryPECTIN, MENTHOLChain Drug Marketing Association, Inc.18d28b91-55a7-4d0d-8404-4f21afdef9892025-12-22WarningsExact identifier
unii: 89NA02M4RX
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart44494842-e38d-617c-e063-6294a90afaf82025-12-20WarningsExact identifier
unii: K679OBS311
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart443e214b-2680-79a9-e063-6294a90a68ba2025-12-20WarningsExact identifier
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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