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

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 Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69951-001-032025-02-26C16284748780-12cef2736-78bb-d83d-e063-dadaa90ab31fPrevention Oncology Mouth Rinse
69951-001-162025-02-26C16284748780-12cef2736-78bb-d83d-e063-dadaa90ab31fPrevention Oncology Mouth Rinse
69951-001-032025-01-30C16284748780-12cef2736-78bb-d83d-e063-dadaa90ab31fPrevention Oncology Mouth Rinse
69951-001-162025-01-30C16284748780-12cef2736-78bb-d83d-e063-dadaa90ab31fPrevention 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

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