PREOP

Product NDC
72655-201
Requested package NDC
72655-201-01
11-digit product format
726550201
Labeler code
72655
Product ID
72655-201_f1a5754f-d292-44e8-9489-b91c8efc62c2
Type
HUMAN OTC DRUG
Nonproprietary name
Pre-Treatment Antiseptic Rinse
Dosage form
RINSE
Route
ORAL
Labeler
Everbrands, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-01
Marketing end
0000-00-00
Substance
HYDROGEN PEROXIDE
Active strength
27 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72655-20172655-201-01DDiscontinued by firm2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07cba15c-4adc-1039-9ab9-45f5b7e84f4fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72655-201-012023-01-30C16284748780-1f386c649-99c9-0266-e053-dadaa90a7c1aPREOP Pre-Treatment Antiseptic Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72655-201-01PREOP475 mL in 1 BOTTLE, PUMPRINSE4752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72655-201PREOP (HYDROGEN PEROXIDE) RINSE PREOP (PRE-TREATMENT ANTISEPTIC RINSE) RINSE [EVERBRANDS, INC.]1Legacy NDC, 1 package rows20210310_cc5cdd29-92c1-4ce0-997e-eb624b288b09.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
ndc (package): 72655-201-01
ndc (product): 72655-201
ndc11 (package): 72655020101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2530801hydrogen peroxide 2.65 % MouthwashPSNcc5cdd29-92c1-4ce0-997e-eb624b288b092
2530808PreOp 2.65 % MouthwashPSNcc5cdd29-92c1-4ce0-997e-eb624b288b092
2530808hydrogen peroxide 26.5 MG/ML Mouthwash [Preop]SBDcc5cdd29-92c1-4ce0-997e-eb624b288b092
2530801hydrogen peroxide 26.5 MG/ML MouthwashSCDcc5cdd29-92c1-4ce0-997e-eb624b288b092
2530801hydrogen peroxide 2.65 % Oral RinseSYcc5cdd29-92c1-4ce0-997e-eb624b288b092
2530808Preop 2.65 % Oral RinseSYcc5cdd29-92c1-4ce0-997e-eb624b288b092
2530808Preop 26.5 MG/ML MouthwashSYcc5cdd29-92c1-4ce0-997e-eb624b288b092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72655-201-0172655020101475 mL in 1 BOTTLE, PUMP (72655-201-01) 475 ml2021-03-010000-00-00NoNoCurrent