Home NDC 84126-603-01 Oral B Mouth Sore
Product NDC 84126-603
Requested package NDC 84126-603-01
11-digit product format 841260603
Labeler code 84126
Product ID 84126-603_5ee9e950-4b9b-8320-e063-6294a90aa331
Type HUMAN OTC DRUG
Nonproprietary name Hydrogen Peroxide
Dosage form RINSE
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-02
Substance HYDROGEN PEROXIDE
Active strength .03 mL/20mL
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 Oral B Mouth Sore
Brand name suffix Special Care Rinse
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROGEN PEROXIDE .03 mL/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BBX060AN9V Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84126-603-08 Oral B Mouth SoreSpecial Care Rinse 237 mL in 1 BOTTLE, PLASTIC RINSE 237 7 84126-603-16 Oral B Mouth SoreSpecial Care Rinse 475 mL in 1 BOTTLE, PLASTIC RINSE 475 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84126-603 ORAL B MOUTH SORE SPECIAL CARE RINSE (HYDROGEN PEROXIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 Current NDC, 2 package rows 20250213_22e2dc15-5794-28ed-e063-6394a90a36d3.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 9 of 48 · 950 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arm and Hammer SODIUM FLUORIDE Church & Dwight Co., Inc. 545258fd-8179-fffc-e063-6394a90a467f 2026-06-01 Warnings Exact identifier application number: M021 Orajel Paw Patrol SODIUM FLUORIDE Church & Dwight Co., Inc. 99d87bea-3e99-5d04-e053-2a95a90aaf54 2026-06-01 Warnings Exact identifier application number: M021 Orajel SuperMario ANTICAVITY TOOTHPASTE Church & Dwight Co., Inc. 27d2f6cb-8661-da9c-e063-6394a90a5bde 2026-06-01 Warnings Exact identifier application number: M021 Orajel KidsToothpaste SODIUM FLUORIDE Church & Dwight Co., Inc. 99d62125-c2c5-5926-e053-2995a90aaa29 2026-06-01 Warnings Exact identifier application number: M021 AIM CAVITY PROTECTION Multi Benefit SODIUM FLUORIDE Church & Dwight Co., Inc. 1d0f8a33-0b01-40e2-e054-00144ff88e88 2026-06-01 Warnings Exact identifier application number: M021 Crest plus Tartar Protection Whitening SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 560980ea-749f-593d-e063-6394a90a1b9e 2026-06-01 Warnings Exact identifier application number: M021 Colgate Revitalizing White SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company c67223ae-b068-41c5-a15b-7ae9840b93ef 2026-05-27 Warnings Exact identifier application number: M021 Colgate Kids Harry Potter SODIUM FLUORIDE Colgate-Palmolive Company 61c06da4-9f02-4fbc-b80f-1c443e298496 2026-05-26 Warnings Exact identifier application number: M021 sodium fluoride rinse SODIUM FLUORIDE RINSE Rockland Cosmetics, Inc. 52430b12-4d5f-d1e1-e063-6394a90abd64 2026-05-20 Warnings, Adverse reactions Exact identifier application number: M021 Anticavity SODIUM FLUORIDE H E B d0a52519-3339-40ea-93e5-78f76d348a4d 2026-05-14 Warnings, Adverse reactions Exact identifier application number: M021 Burts Bees Extra White SODIUM FLUORIDE Procter & Gamble Manufacturing Company c92524fd-8b93-592d-e053-2a95a90a88c6 2026-05-13 Warnings Exact identifier application number: M021 MIPaste Plus Strawberry SODIUM FLUORIDE GC America Inc. 1b68bd67-65d3-4c64-e054-00144ff8d46c 2026-05-12 Warnings Exact identifier application number: M021 White Glo Purple Color Corrector Fluoride Anticavity SODIUM MONOFLUOROPHOSPHATE White Glo USA Inc 6f8b77c3-9833-4c75-b41c-a2bc12616157 2026-05-12 Warnings Exact identifier application number: M021 botalab HERBAL COMPLETE TOOTH SODIUM FLUORIDE KMPHARMACEUTICAL CO., LTD. 51365ef7-ed94-2650-e063-6394a90ab89e 2026-05-07 Warnings Exact identifier application number: M021 Morning Fresh Mint Toothpaste, with Fluoride MORNING FRESH MINT TOOTHPASTE, WITH FLUORIDE Dynarex Corporation 2a42d8ce-e7f2-caa5-e063-6294a90ac01f 2026-05-07 Warnings Exact identifier application number: M021 Frida Fluoride Sweet Mint SODIUM FLUORIDE Fridababy, LLC 4f8b5a39-5d79-72cd-e063-6394a90a475c 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Bubble Mint SODIUM FLUORIDE Fridababy, LLC 4f8b9af3-e4b3-b5e0-e063-6394a90a1068 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry Toothbrush Set SODIUM FLUORIDE Fridababy, LLC 4f8ba14f-60ea-c2a8-e063-6394a90a7702 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry SODIUM FLUORIDE Fridababy, LLC 4f814a62-8f91-8ea6-e063-6294a90a69eb 2026-05-06 Warnings Exact identifier application number: M021 Gum Health Detoxify STANNOUS FLUORIDE Meijer, Inc 41d70733-a223-40fb-e063-6294a90a1397 2026-05-06 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84126-603-01 84126060301 473 mL in 1 BOTTLE, PLASTIC (84126-603-01) 473 ml 2026-11-02 No No Current