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…

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 1 of 42 · 825 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022
Ludens Watermelon Throat DropsPECTINPrestige Brands Holdings, Inc.adfb248a-96bb-4742-9df6-c47edccdd6712026-08-20WarningsExact 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