FDA.reportPublic FDA data

Hydrogen Peroxide

Product NDC
0363-0268
11-digit product format
003630268
Labeler code
0363
Product ID
0363-0268_eca7e851-92e3-4c39-b88b-bbb0460ac72f
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Walgreens
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-30
Substance
HYDROGEN PEROXIDE
Active strength
2.65 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
Brand name suffix
3 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE2.65 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
c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56faAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0363-0268-162023-10-09Drug Facts
0363-0268-322023-10-09Drug Facts
0363-0268-162023-01-30Drug Facts
0363-0268-322023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0268-16Hydrogen Peroxide3 Percent473 mL in 1 BOTTLE, PLASTICLIQUID4738
0363-0268-32Hydrogen Peroxide3 Percent946 mL in 1 BOTTLE, PLASTICLIQUID9468

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0268-16ML - Milliliter0363-02686aaf3de7-a53d-4abd-b57a-d98ce668bbb212022-06-06
0363-0268-32ML - Milliliter0363-02687e282ba8-297a-4ff5-b0f6-7760559a8ccf12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9VHYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [WALGREENS]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VHYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [WALGREENS]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0268HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [WALGREENS]8Current NDC, Legacy NDC, 2 package rows20250223_c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa.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 37 of 39 · 774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact identifier
application number: M022
Moon Charcoal Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c55f7b3-fea1-58f3-e063-6394a90a3bde2023-12-12WarningsExact identifier
application number: M022
ORCA Complete Menthol Pain RelieverMENTHOLORCA Products, LLC99990e27-d66b-4d61-97f2-6a76066eb8b82023-12-08WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc0070858b-e02e-431f-a7c2-313fef01791b2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incd1802f08-80cb-41dd-b34d-9c576b101ddb2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
91349hydrogen peroxide 3 % Topical SolutionPSNc4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa8
91349hydrogen peroxide 30 MG/ML Topical SolutionSCDc4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa8
91349hydrogen peroxide 3 % Topical SolutionSYc4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0268-1600363026816473 mL in 1 BOTTLE, PLASTIC (0363-0268-16) 473 ml2015-04-300000-00-00NoNoCurrent
0363-0268-3200363026832946 mL in 1 BOTTLE, PLASTIC (0363-0268-32) 946 ml2015-04-300000-00-00NoNoCurrent