FDA.reportPublic FDA data

Hydrogen Peroxide

Product NDC
53441-268
Requested package NDC
53441-268-16
11-digit product format
534410268
Labeler code
53441
Product ID
53441-268_0da3a6cf-bc0e-4821-8947-90b598501f2b
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
National Distribution Network (Smart Choice)
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-31
Marketing end
2021-12-31
Substance
HYDROGEN PEROXIDE
Active strength
3 mL/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage53441-26853441-268-16DDiscontinued by firm2026-09-14

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 · 12 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…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9VHYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VHYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53441-268-1653441026816473 mL in 1 BOTTLE, PLASTIC (53441-268-16) 473 ml2014-10-312021-12-31NoNoCurrent