PerioRestore

Product NDC
59883-018
11-digit product format
598830018
Labeler code
59883
Product ID
59883-018_0a0d08d7-e3f3-d98d-e063-6394a90af5e9
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
GEL
Route
DENTAL
Labeler
DEN-MAT HOLDINGS, LLC.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-15
Substance
HYDROGEN PEROXIDE
Active strength
17 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
PerioRestore
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
97a07c36-1af8-a636-e053-2a95a90ad6dbAvailable 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
59883-018-87PerioRestore85 g in 1 TUBEGEL853
59883-018-87PerioRestore1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-018PERIORESTORE (HYDROGEN PEROXIDE) GEL [DEN-MAT HOLDINGS, LLC.]3Current NDC, Legacy NDC, 2 package rows20231216_97a07c36-1af8-a636-e053-2a95a90ad6db.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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
application number: M022
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
application number: M022
SEXYTEETH CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
application number: M022
Gingicaine Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
application number: M022
3ECARE Dual formula WhiteningToothpaste RefillSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.501df1c7-4884-bb39-e063-6294a90aaf6a2026-04-23WarningsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
application number: M022
EverSmile AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
application number: M022
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
application number: M022
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
application number: M022
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsExact identifier
application number: M022
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095271hydrogen peroxide 1.7 % Oral GelPSN97a07c36-1af8-a636-e053-2a95a90ad6db3
1095271hydrogen peroxide 0.017 MG/MG Oral GelSCD97a07c36-1af8-a636-e053-2a95a90ad6db3
1095271hydrogen peroxide 1.7 % Oral GelSY97a07c36-1af8-a636-e053-2a95a90ad6db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-018-87598830018871 TUBE in 1 BOX (59883-018-87) / 85 g in 1 TUBE1 tube2019-07-150000-00-00NoNoCurrent