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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact 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