Peroxyl Mouth Sore Mild Mint

Product NDC: 0126-0083
Requested package NDC: 0126-0083-31
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0126-0083	0126-0083-31	D	Discontinued by firm		2026-09-14

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Peroxyl Mouth Sore Mild Mint
Listing expiration: 2026-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b1e1b7c9-dea7-4d64-b6a8-5343f4176359	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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
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 1 of 42 · 825 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Opalescence Whitening Sensitivity Relief	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	44e94663-895b-67da-e063-6394a90a5fe6	2026-09-09	Warnings	Exact identifier application number: M022
Opalescence Sensitivity Relief Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	b5176a84-76a3-4ad0-a2e2-4997a12da9a5	2026-09-09	Warnings	Exact identifier application number: M022
Opal by Opalescence Sensitivity	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	5ffc0d14-0290-47bb-90e5-90a25a5acc28	2026-09-09	Warnings	Exact identifier application number: M022
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier application number: M022
SORE THROAT	PHENOL	Raritan Pharmaceuticals Inc	43ce374a-824c-4034-bf04-c351b4d8015b	2026-09-08	Warnings	Exact identifier application number: M022
Colgate Optic White Stain Fighter Sens Relief	SODIUM FLUORIDE	Colgate-Palmolive Company	6ec2fff7-df44-4302-be2d-97946c6cd66a	2026-09-08	Warnings	Exact identifier application number: M022
DRx Choice Sore Throat Menthol Flavor	PHENOL	RARITAN PHARMACEUTICALS INC	e3269b12-5c05-45a6-81f2-65d9f016c3aa	2026-09-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	0733015b-e81a-4a62-82ad-dacaf3f163cb	2026-09-02	Warnings	Exact identifier application number: M022
KROGER Saline	NASAL	KROGER COMPANY	c84b242b-f46e-4ea8-a3c1-109a47644646	2026-09-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	ceb125d9-8c1b-498c-b0f0-f18756ede442	2026-09-01	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT	HEXYLRESORCINOL	Reckitt Benckiser LLC	91cd2964-5d83-4e40-bc18-e3e5462f454a	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier application number: M022
LUDENS SUGAR FREE WILD CHERRY THROAT	PECTIN	Prestige Brands Holdings, Inc.	274fc80c-e5b2-41c7-a119-287d6e8a2258	2026-08-28	Warnings	Exact identifier application number: M022
Medline Peroxi Fresh Mouthwash	HYDROGEN PEROXIDE	Medline Industries, LP	ec7a9240-6c66-4471-b8b6-776e08a14fbc	2026-08-27	Warnings	Exact identifier application number: M022
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M022
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BBX060AN9V	HYDROGEN PEROXIDE	7722-84-1	HYDROGEN PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
358975	hydrogen peroxide 1.5 % Mouthwash	PSN	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	18
1727009	Peroxyl 1.5 % Mouthwash	PSN	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	18
1727009	hydrogen peroxide 15 MG/ML Mouthwash [Peroxyl]	SBD	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	18
358975	hydrogen peroxide 15 MG/ML Mouthwash	SCD	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	18
358975	hydrogen peroxide 1.5 % Mouthwash	SY	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	18
1727009	Peroxyl 1.5 % Mouthwash	SY	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	18
1727009	Peroxyl 15 MG/ML Mouthwash	SY	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	18
358975	hydrogen peroxide 1.5 % Mouthwash	PSN	818575ec-5136-4d4f-a0d4-51a7770499be	1
1727009	Peroxyl 1.5 % Mouthwash	PSN	818575ec-5136-4d4f-a0d4-51a7770499be	1
1727009	hydrogen peroxide 15 MG/ML Mouthwash [Peroxyl]	SBD	818575ec-5136-4d4f-a0d4-51a7770499be	1
358975	hydrogen peroxide 15 MG/ML Mouthwash	SCD	818575ec-5136-4d4f-a0d4-51a7770499be	1
358975	hydrogen peroxide 1.5 % Mouthwash	SY	818575ec-5136-4d4f-a0d4-51a7770499be	1
1727009	Peroxyl 1.5 % Mouthwash	SY	818575ec-5136-4d4f-a0d4-51a7770499be	1
1727009	Peroxyl 15 MG/ML Mouthwash	SY	818575ec-5136-4d4f-a0d4-51a7770499be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0126-0083-31	00126008331	946 mL in 1 BOTTLE (0126-0083-31)	946 ml	2020-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Peroxyl ® Mouth Sore Mild Mint	Colgate Oral Pharmaceuticals Inc. \| COLGATE PALMOLIVE COMPANY	2024-11-25	HUMAN OTC DRUG LABEL	18
PEROXYL ® MOUTH SORE RINSE MILD MINT	Colgate Oral Pharmaceuticals, Inc.	2015-09-08	HUMAN OTC DRUG LABEL	1