FDA.reportPublic FDA data

OMNI

Product NDC
48878-4061
11-digit product format
488784061
Labeler code
48878
Product ID
48878-4061_5f88065a-e74d-4285-93d2-b208bf197523
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL
Route
ORAL
Labeler
Solventum US LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-02-01
Substance
STANNOUS FLUORIDE
Active strength
.969 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
OMNI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.969 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c2a81b1-65b5-432b-8e66-30432a245abaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48878-4061-3OMNI1 in 1 BOXGEL17
48878-4061-3OMNI121.9 g in 1 TUBEGEL121.97

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48878-4061-3GM - Gram48878-40611f7fc579-833d-4901-900b-b696ab0a91af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
stannous fluorideACTIVE INGREDIENT3FTR44B32QOMNI (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1
fluoride ionACTIVE MOIETYQ80VPU408OOMNI (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXOMNI (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1
hydroxyethyl cellulose (2000 cps at 1%)INACTIVE INGREDIENTS38J6RZN16OMNI (STANNOUS FLUORIDE) GEL [3M ESPE DENTAL PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48878-4061OMNI (STANNOUS FLUORIDE) GEL [SOLVENTUM US LLC]7Current NDC, Legacy NDC, 2 package rows20240808_0c2a81b1-65b5-432b-8e66-30432a245aba.zip

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 15 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32ebc633-5338-4d5a-b075-f10b247612482026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEH E B51ddc81b-1c90-4998-b538-6761ac1134372026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.9a0b6301-2443-41f7-adeb-87578a65c26d2026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.344c9d00-ad82-46a9-83e9-68197e1a68bb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Complete Oral RinseANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.27c33ae1-52c7-baad-e063-6394a90a06112026-02-23WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.001777fb-196c-499a-94c8-6cdcef0958e92026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.c628d02f-c834-42b3-b38d-6b9cdcdd09612026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.b17f7a5d-272e-446d-803b-46a6d8e5f18f2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEMeijer, Inc.d85ce60c-ebff-461f-827a-10fddb9c2bf32026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
White Glo Charcoal Baking Soda Maximum White Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc580c4622-6f9c-48ea-b01e-6ffba7273f242026-02-19WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Incf044e213-2403-4f42-a41d-72d58fefcfcb2026-02-19WarningsExact identifier
application number: M021
White Glo Mouthwash Protect Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4691584f-8c0c-4589-8b40-89b1779a438d2026-02-19WarningsExact identifier
application number: M021
White Glo Professional Choice Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inced8d7506-0385-4422-be77-bcc2db79882f2026-02-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEMeijer, Inc.c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEMeijer, Inc.af34f83f-1328-4897-9d04-72ca5a4101bf2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.acff939e-e98c-4d89-a0c4-0254dc74e6722026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDEMeijer, Inc.0bb9fb5f-1893-4187-b60b-05319a8fac6a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Intense Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC4b0404af-309f-7c31-e063-6294a90a5aa12026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETarget Corporationabfc1973-60ab-44e5-8147-33739d8bd7a32026-02-18Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETarget Corporation3e4119b2-9506-4305-8cff-163f700265d02026-02-18Warnings, Adverse reactionsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48878-4061-3488784061031 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE1 tube1998-02-010000-00-00NoNoCurrent