FDA.reportPublic FDA data

3% HYDROGEN PEROXIDE

Product NDC
84809-005
Requested package NDC
84809-005-03
11-digit product format
848090005
Labeler code
84809
Product ID
84809-005_3b9d65a2-39a5-08f0-e063-6394a90a4c91
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
LJ Pharma
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-30
Substance
HYDROGEN PEROXIDE
Active strength
3 mL/100mL
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
3% HYDROGEN PEROXIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE3 mL/100mL

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
91349Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e468ad76-b26a-49f0-a2c5-a027299babc7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84809-005-013% HYDROGEN PEROXIDE236 mL in 1 BOTTLE, SPRAYLIQUID2362
84809-005-013% HYDROGEN PEROXIDE12 in 1 CARTONLIQUID122
84809-005-023% HYDROGEN PEROXIDE473 mL in 1 BOTTLE, SPRAYLIQUID4732
84809-005-023% HYDROGEN PEROXIDE12 in 1 CARTONLIQUID122
84809-005-033% HYDROGEN PEROXIDE946 mL in 1 BOTTLE, SPRAYLIQUID9462
84809-005-033% HYDROGEN PEROXIDE12 in 1 CARTONLIQUID122

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 59 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting and BiteBENZOCAINEPHOENIX HEALTHCARE SOLUTIONS, LLC82791832-1357-48ca-91d4-1328997012612025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
application number: M003
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
application number: M003
Koala Eco Hand SanitizerETHYL ALCOHOLKoala Eco Company USA Ltd41d7d6e3-9961-770d-e063-6394a90a0d242025-10-23WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ NORISC ANTIBACTERIAL SKIN CAREBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONf93c55f9-b3e1-45f6-8e0d-09e60f5b822f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - NORISC - INCONTINENT WASHBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONed26fa74-5ae8-4294-b61d-682d6ad4b32a2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSERBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONd06b0489-86d3-4bf1-928f-fc524a71560e2025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack-BASEALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc86458169-92eb-45a5-b3cc-6eccd8caa1e82025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack BASESODIUM MONOFLUOROPHOSPATEALLIANCE FORMULATIONS5d0e768f-086c-4b8c-b618-6dde70f302f92025-10-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a5db85-05b8-ecd6-e063-6394a90ac3872025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a62d9f-4d46-f8ca-e063-6294a90ae1ed2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a69d10-f7bf-cf17-e063-6294a90a177d2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a7735f-03b7-4fdc-e063-6394a90a100b2025-10-21WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b6ee3f-55f4-0502-e063-6394a90aa3572025-10-21WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tangy TerraneALCOHOLShenzhen Lantern Scicence Co.,Ltd.4192dbc6-5d9a-d42a-e063-6394a90aa2d82025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Sweet and StillALCOHOLShenzhen Lantern Scicence Co.,Ltd.41934870-d87e-1c51-e063-6294a90abd2d2025-10-20WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
91349hydrogen peroxide 3 % Topical SolutionPSNe468ad76-b26a-49f0-a2c5-a027299babc72
91349hydrogen peroxide 30 MG/ML Topical SolutionSCDe468ad76-b26a-49f0-a2c5-a027299babc72
91349hydrogen peroxide 3 % Topical SolutionSYe468ad76-b26a-49f0-a2c5-a027299babc72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84809-005-038480900050312 BOTTLE, SPRAY in 1 CARTON (84809-005-03) / 946 mL in 1 BOTTLE, SPRAY2025-08-04NoNoCurrent