FDA.reportPublic FDA data

Prevention Oncology Mouth Rinse

Product NDC
69951-001
11-digit product format
699510001
Labeler code
69951
Product ID
69951-001_2ea9338d-fc20-b029-e063-6394a90a8a6e
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
LIQUID
Route
ORAL
Labeler
Prevention Health Sciences, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-10
Substance
GLYCERIN
Active strength
4.5 mg/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69951-001-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69951-001-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69951-001-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69951-001-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69951-001-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69951-001-030efc9e666f02…f202fb6c5f17…

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
Prevention Oncology Mouth Rinse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN4.5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ec9ed1c-bcb6-3a0a-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69951-001-032025-02-26Prevention Oncology Mouth Rinse
69951-001-162025-02-26Prevention Oncology Mouth Rinse
69951-001-032025-01-30Prevention Oncology Mouth Rinse
69951-001-162025-01-30Prevention Oncology Mouth Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69951-001-03Prevention Oncology Mouth Rinse95 mL in 1 BOTTLE, PLASTICLIQUID955
69951-001-16Prevention Oncology Mouth Rinse473 mL in 1 BOTTLE, PLASTICLIQUID4735

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
GLYCERINACTIVE MOIETYPDC6A3C0OXPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
HYDROGEN PEROXIDEINACTIVE INGREDIENTBBX060AN9VPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2PREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BPREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69951-001PREVENTION ONCOLOGY MOUTH RINSE (GLYCERIN) LIQUID [PREVENTION HEALTH SCIENCES, INC.]5Current NDC, Legacy NDC, 2 package rows20250228_1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c.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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69951-001-036995100010395 mL in 1 BOTTLE, PLASTIC (69951-001-03) 95 ml2023-01-100000-00-00NoNoCurrent
69951-001-1669951000116473 mL in 1 BOTTLE, PLASTIC (69951-001-16) 473 ml2023-01-100000-00-00NoNoCurrent