PERIOGELX

Product NDC
83381-3206
11-digit product format
833813206
Labeler code
83381
Product ID
83381-3206_51c8a67c-a13b-1d7e-e063-6294a90a78ee
Type
HUMAN OTC DRUG
Nonproprietary name
HYDROGEN PEROXIDE
Dosage form
GEL
Route
DENTAL
Labeler
PERIO PROTECT, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
HYDROGEN PEROXIDE
Active strength
17 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
PERIOGELX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE17 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BBX060AN9VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1095271Internal RxNorm lookup
2743349Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e5a67a0-f989-50df-e063-6394a90aae73Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83381-3206-1PERIOGELX1 in 1 BOXGEL12
83381-3206-1PERIOGELX85 g in 1 TUBEGEL852

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 33 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola Ag908f5ce5-94a4-4c35-ae7a-b308ea37fa082024-12-05WarningsExact identifier
application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola Aga6657ecf-e74a-4912-a68c-73abc456f9e22024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag67373cf1-e8c3-4db2-98e1-c88d25a762092024-12-05WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag586b2a46-2673-4f27-a62a-2d48a9b520ab2024-12-05WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola Aga2bdd035-4678-4cff-b24f-8e2f06acad962024-12-05WarningsExact identifier
application number: M022
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore RinseHYDROGEN PEROXIDE, MENTHOLChurch & Dwight Co., Inc.99d47d6a-fa2e-d5ee-e053-2995a90aa11d2024-11-27WarningsExact identifier
application number: M022
Orajel 2x Gum Pain Alcohol-FreeMENTHOL AND HYDROGEN PEROXIDEChurch & Dwight Co., Inc.adf37010-922c-4441-93d6-1e1a95025e902024-11-27WarningsExact identifier
application number: M022
Maximum Strength Cold Sore TreatmentCAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUMMeijer Distribution Inc9220772c-b3b7-4855-e053-2a95a90a94f62024-11-27WarningsExact identifier
application number: M022
Peroxyl Mouth Sore Mild MintHYDROGEN PEROXIDEColgate Oral Pharmaceuticals Inc.b1e1b7c9-dea7-4d64-b6a8-5343f41763592024-11-25WarningsExact identifier
application number: M022
NICE SORE THROAT SpearmintPHENOLLeosons Overseas Corp5fc68f04-ec15-11c0-e053-2a91aa0a19522024-11-20WarningsExact identifier
application number: M022
TANAC Oral Pain RelieverBENZOCAINELeosons Overseas Corp81cc61fa-31a7-2214-e053-2a91aa0ae46a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT Honey LemonPHENOLLeosons Overseas Corp601aea98-e6ab-de6f-e053-2a91aa0a824a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT CherryPHENOLLeosons Overseas Corp5f21694c-d1c9-0e64-e053-2a91aa0a0ff02024-11-15WarningsExact identifier
application number: M022
Sore ThroatPHENOLSafeway, Inc.f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d2024-11-14WarningsExact identifier
application number: M022
Sore Throat Relief CherryPHENOLBest Choice (Valu Merchandisers Company)c0a47d59-3e15-453d-97a7-d626e86508622024-11-14WarningsExact identifier
application number: M022
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095271hydrogen peroxide 1.7 % Oral GelPSN4e5a67a0-f989-50df-e063-6394a90aae732
2743349PerioGel 1.7 % Oral GelPSN4e5a67a0-f989-50df-e063-6394a90aae732
2743349hydrogen peroxide 0.017 MG/MG Oral Gel [Periogel]SBD4e5a67a0-f989-50df-e063-6394a90aae732
1095271hydrogen peroxide 0.017 MG/MG Oral GelSCD4e5a67a0-f989-50df-e063-6394a90aae732
1095271hydrogen peroxide 1.7 % Oral GelSY4e5a67a0-f989-50df-e063-6394a90aae732
2743349Periogel 0.017 MG/MG Oral GelSY4e5a67a0-f989-50df-e063-6394a90aae732
2743349Periogel 1.7 % Oral GelSY4e5a67a0-f989-50df-e063-6394a90aae732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83381-3206-1833813206011 TUBE in 1 BOX (83381-3206-1) / 85 g in 1 TUBE1 tube2026-01-01NoNoCurrent