Home NDC 0126-0083 Peroxyl Mouth Sore Mild Mint
Product NDC 0126-0083
11-digit product format 001260083
Labeler code 0126
Product ID 0126-0083_0df671b6-d668-41ee-935d-838a62924b58
Type HUMAN OTC DRUG
Nonproprietary name Hydrogen Peroxide
Dosage form RINSE
Route BUCCAL
Labeler Colgate Oral Pharmaceuticals Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-01-01
Substance HYDROGEN PEROXIDE
Active strength 15 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 Peroxyl Mouth Sore Mild Mint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROGEN PEROXIDE 15 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 358975 Internal RxNorm lookup 1727009 Internal RxNorm 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 0126-0083-16 Peroxyl Mouth Sore Mild Mint 500 mL in 1 BOTTLE, PLASTIC RINSE 500 18 0126-0083-22 Peroxyl Mouth Sore Mild Mint 1000 mL in 1 BOTTLE RINSE 1000 18 0126-0083-31 Peroxyl Mouth Sore Mild Mint 946 mL in 1 BOTTLE RINSE 946 18 0126-0083-70 Peroxyl Mouth Sore Mild Mint 10 mL in 1 POUCH RINSE 10 18 0126-0083-70 Peroxyl Mouth Sore Mild Mint 50 in 1 CARTON RINSE 50 18 0126-0083-99 Peroxyl Mouth Sore Mild Mint 250 mL in 1 BOTTLE, PLASTIC RINSE 250 18 0126-0083-70 PEROXYL MOUTH SORE MILD MINT 50 in 1 CARTON RINSE 50 1 0126-0083-70 PEROXYL MOUTH SORE MILD MINT 10 mL in 1 POUCH RINSE 10 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrogen Peroxide ACTIVE INGREDIENT BBX060AN9V PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Hydrogen Peroxide ACTIVE MOIETY BBX060AN9V PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Poloxamer 338 INACTIVE INGREDIENT F75JV2T505 PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0126-0083 PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS INC.] 18 Current NDC, Legacy NDC, 6 package rows 20241127_b1e1b7c9-dea7-4d64-b6a8-5343f4176359.zip 0126-0083 PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20151218_818575ec-5136-4d4f-a0d4-51a7770499be.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 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0126-0083-16 00126008316 500 mL in 1 BOTTLE, PLASTIC (0126-0083-16) 500 ml 2009-01-01 0000-00-00 No No Current 0126-0083-22 00126008322 1000 mL in 1 BOTTLE (0126-0083-22) 1000 ml 2020-08-31 0000-00-00 No No Current 0126-0083-31 00126008331 946 mL in 1 BOTTLE (0126-0083-31) 946 ml 2020-08-29 0000-00-00 No No Current 0126-0083-70 00126008370 50 POUCH in 1 CARTON (0126-0083-70) / 10 mL in 1 POUCH 50 pouch 2017-03-15 0000-00-00 No No Current 0126-0083-99 00126008399 250 mL in 1 BOTTLE, PLASTIC (0126-0083-99) 250 ml 2015-01-01 0000-00-00 No No Current