FDA.reportPublic FDA data

Hydrogen Peroxide

Product NDC
10565-001
11-digit product format
105650001
Labeler code
10565
Product ID
10565-001_483334b6-155a-fc0c-e063-6394a90a1228
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hydrox Laboratories
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-09-01
Substance
HYDROGEN PEROXIDE
Active strength
3 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Hydrogen Peroxide
Listing expiration
2027-12-31

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
6e5709b4-cc56-4768-b704-1d9b0e3efec7Available 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
10565-001-04Hydrogen Peroxide118 mL in 1 BOTTLE, PLASTICSOLUTION11812
10565-001-08Hydrogen Peroxide237 mL in 1 BOTTLE, PLASTICSOLUTION23712
10565-001-16Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION47312
10565-001-32Hydrogen Peroxide946 mL in 1 BOTTLE, PLASTICSOLUTION94612
10565-001-99Hydrogen Peroxide3800 mL in 1 BOTTLE, PLASTICSOLUTION380012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10565-001-04ML - Milliliter10565-00196c075eb-0e34-48ce-9cf3-5e43bd4c0d8b12013-11-04
10565-001-08ML - Milliliter10565-00143e22aee-a140-49b0-bb24-341ae5c20ceb12013-11-04
10565-001-16ML - Milliliter10565-001b23f3e02-7955-4725-ad2e-4c902503722d12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrogen PeroxideACTIVE INGREDIENTBBX060AN9VHYDROGEN PEROXIDE SOLUTION [HYDROX LABORATORIES]1
Hydrogen PeroxideACTIVE MOIETYBBX060AN9VHYDROGEN PEROXIDE SOLUTION [HYDROX LABORATORIES]1
WaterINACTIVE INGREDIENT059QF0KO0RHYDROGEN PEROXIDE SOLUTION [HYDROX LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-001HYDROGEN PEROXIDE SOLUTION [HYDROX LABORATORIES]11Current NDC, Legacy NDC, 5 package rows20231027_6e5709b4-cc56-4768-b704-1d9b0e3efec7.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 71 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3bd802-56de-ebcd-e063-6294a90aca152025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Wild RoseALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3c78f6-e6cb-e456-e063-6394a90ac5b82025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c4bceac-21bc-486e-e063-6394a90a0f372025-08-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c25e093-0335-fa1d-e063-6394a90ae6842025-08-12WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c266de8-0551-374c-e063-6394a90ab9f42025-08-12WarningsExact identifier
application number: M003
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEHAIAN KANGRUI TEXTILE CO., LTD.3c273544-4562-8f37-e063-6394a90ab4d32025-08-12WarningsExact identifier
application number: M003
HealthWise Lidocaine CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEVeridian Healthcare6022803a-097e-41c6-b9ee-48c8ef380d7a2025-08-12WarningsExact identifier
application number: M003
Hand Sanitizer WipesISOPROPYL ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c37f72b-623c-c8f6-e063-6294a90a971e2025-08-12WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c236c0b-fccd-6992-e063-6294a90a37ce2025-08-11WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c2322e0-90d5-6ce6-e063-6394a90ac8bb2025-08-11WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c23d45e-9050-5b9e-e063-6294a90abd4a2025-08-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafetec of America, Inc.89310a64-c4cc-46c6-8294-c4d28cd881182025-08-08WarningsExact identifier
application number: M003
365 Whole Foods Market Refreshing Hand Sanitizer Citrus SunshineETHYL ALCOHOLWhole Foods Market, Inc.3bcf1071-2308-b989-e063-6294a90a68232025-08-07WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDELJ Pharmae468ad76-b26a-49f0-a2c5-a027299babc72025-08-05WarningsExact identifier
application number: M003
Armor Antibacterial Body Treatment Benzalkonium ChlorideBENZALKONIUM CHLORIDERida LLC95761213-bf90-4ba6-a17b-7470a0f316232025-08-05WarningsExact identifier
application number: M003
AerowipeANSTISEPTIC WIPEAero Healthcare34ca12c7-9281-263c-e054-00144ff8d46c2025-08-01WarningsExact identifier
application number: M003
KeriCleanz ANTISEPTICHYDROGEN PEROXIDEKericure Inc.79b0d9bb-0fa5-4e45-ab74-9ff0e12152382025-07-31WarningsExact identifier
application number: M003
Caring Mill Alcohol Prep PadsISOPROPYL ALCOHOLFSA Store Inc.3b394791-0783-79e1-e063-6294a90ae8e72025-07-31WarningsExact identifier
application number: M003
WICKED HAND SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e9352-15c9-954a-e063-6294a90a7a672025-07-29WarningsExact identifier
application number: M003
WICKED HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e7e57-6472-6cca-e063-6294a90a63a62025-07-29WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN6e5709b4-cc56-4768-b704-1d9b0e3efec712
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD6e5709b4-cc56-4768-b704-1d9b0e3efec712
91349hydrogen peroxide 3 % Topical SolutionSY6e5709b4-cc56-4768-b704-1d9b0e3efec712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-001-0410565000104118 mL in 1 BOTTLE, PLASTIC (10565-001-04) 118 ml1993-09-010000-00-00NoNoCurrent
10565-001-0810565000108237 mL in 1 BOTTLE, PLASTIC (10565-001-08) 237 ml1993-09-010000-00-00NoNoCurrent
10565-001-1610565000116473 mL in 1 BOTTLE, PLASTIC (10565-001-16) 473 ml1993-09-010000-00-00NoNoCurrent
10565-001-3210565000132946 mL in 1 BOTTLE, PLASTIC (10565-001-32) 946 ml1993-09-010000-00-00NoNoCurrent
10565-001-99105650001993800 mL in 1 BOTTLE, PLASTIC (10565-001-99) 3800 ml1993-09-010000-00-00NoNoCurrent