FDA.reportPublic FDA data

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 22 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWinCo Foods, LLC9417b340-942b-48bf-bbfd-4cd5154082b92025-02-12WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCb291811f-8fac-45e2-a9a2-b3ecc0813d0d2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCfea30599-5e3b-4163-9660-d41b3fcee1432025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC3be68966-199c-481e-8b9e-e994c41fd96a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCccdee0cc-2bc9-4165-a411-02f4f900d86a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b72025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC69c4dd1b-a0db-4495-bfc3-faffdfdf59bf2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCd5ef3e65-35e8-4323-9f33-3076b561e1052025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC746df21c-e92e-4a71-b1c6-baf99785a43e2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC2345e614-c7b6-448c-8e07-31700bade91c2025-01-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Belport Company, Inc. DBA Gingi-Pak142062ca-6f8f-78d2-e063-6294a90a19d82025-01-29Warnings, Adverse reactionsExact identifier
application number: M022
CHLORASEPTIC MAXMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.edd12a2d-aa27-4f15-9ce6-862e4b6144c42025-01-23WarningsExact identifier
application number: M022
meijer Sensitive FRESH MINTPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bea36d55-1a5d-40c0-b422-92fb36043ee62025-01-23WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC159d412c-6d1a-45d4-88c0-8c93960f946e2025-01-21WarningsExact identifier
application number: M022
SEACALL MouthwashMOUTHWASHGuangdong Quadrant Ecological Technology Co., Ltd.2c1a7eed-6a7c-eeb2-e063-6394a90aafcc2025-01-19WarningsExact identifier
application number: M022
BENZOCAINE RaspberryBENZOCAINEDarby Dental Supply, LLCdd805400-26c5-4c18-ade2-821298233f9b2025-01-17WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCc68fd8c7-7ec3-cc3f-e053-2995a90a43952025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.d22f7776-1b3c-4744-bcfe-8d9597218d732025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9c6a26e8-1253-49f7-9ce2-45c0d39f05c52025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.48178733-7433-41ec-b178-1314e0edab1a2025-01-16WarningsExact 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