Medline Peroxi Fresh

Product NDC
53329-086
11-digit product format
533290086
Labeler code
53329
Product ID
53329-086_27d6ed9e-98a5-ea13-e063-6394a90adf3b
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
MOUTHWASH
Route
DENTAL
Labeler
Medline Industries, LP
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
Substance
HYDROGEN PEROXIDE
Active strength
15 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53329-08653329-086-13DDiscontinued by firm2026-08-17
excluded packagepackage53329-08653329-086-66DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0553329-086-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553329-086-66d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2653329-086-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653329-086-66f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3153329-086-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3153329-086-662ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2853329-086-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2853329-086-66a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2153329-086-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2153329-086-66cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1053329-086-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1053329-086-66cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3153329-086-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3153329-086-66302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2053329-086-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2053329-086-66ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1053329-086-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1053329-086-660efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0853329-086-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0853329-086-66ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0353329-086-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0353329-086-66367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0953329-086-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0953329-086-66557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Medline Peroxi Fresh
Brand name suffix
Mouthwash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE15 mg/mL

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
358975Internal RxNorm lookup
1038750Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec7a9240-6c66-4471-b8b6-776e08a14fbcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-086-13Medline Peroxi FreshMouthwash59 mL in 1 BOTTLEMOUTHWASH5911
53329-086-14Medline Peroxi FreshMouthwash59 mL in 1 BOTTLEMOUTHWASH5911
53329-086-66Medline Peroxi FreshMouthwash10 mL in 1 PACKETMOUTHWASH1011
53329-086-95Medline Peroxi FreshMouthwash7 mL in 1 PACKETMOUTHWASH711

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-086MEDLINE PEROXI FRESH MOUTHWASH (HYDROGEN PEROXIDE) MOUTHWASH [MEDLINE INDUSTRIES, LP]11Current NDC, Legacy NDC, 4 package rows20241127_ec7a9240-6c66-4471-b8b6-776e08a14fbc.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 · 822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
358975hydrogen peroxide 1.5 % MouthwashPSNec7a9240-6c66-4471-b8b6-776e08a14fbc11
1038750PEROXI-FRESH 1.5 % MouthwashPSNec7a9240-6c66-4471-b8b6-776e08a14fbc11
1038750hydrogen peroxide 15 MG/ML Mouthwash [Peroxi-Fresh]SBDec7a9240-6c66-4471-b8b6-776e08a14fbc11
358975hydrogen peroxide 15 MG/ML MouthwashSCDec7a9240-6c66-4471-b8b6-776e08a14fbc11
358975hydrogen peroxide 1.5 % MouthwashSYec7a9240-6c66-4471-b8b6-776e08a14fbc11
1038750Peroxi-Fresh 1.5 % MouthwashSYec7a9240-6c66-4471-b8b6-776e08a14fbc11
1038750Peroxi-Fresh 15 MG/ML MouthwashSYec7a9240-6c66-4471-b8b6-776e08a14fbc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-086-135332900861359 mL in 1 BOTTLE59 mlHistorical
53329-086-145332900861459 mL in 1 BOTTLE (53329-086-14) 59 ml2017-03-080000-00-00NoNoCurrent
53329-086-665332900866610 mL in 1 PACKET (53329-086-66) 10 ml2007-01-010000-00-00NoNoCurrent
53329-086-95533290086957 mL in 1 PACKET (53329-086-95) 7 ml2019-01-010000-00-00NoNoCurrent