PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH

Product NDC: 62111-0212
11-digit product format: 621110212
Labeler code: 62111
Product ID: 62111-0212_31539b3c-ad6e-4c7f-b464-2c5ed6daa711
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: AKG Innovations LLC
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-02-14
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	62111-0212		I	Inactivated by FDA		2026-10-12
excluded package	package	62111-0212	62111-0212-4	I	Inactivated by FDA		2026-10-12

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62111-0212-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62111-0212-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62111-0212-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62111-0212-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62111-0212-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62111-0212-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62111-0212-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62111-0212-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62111-0212-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62111-0212-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62111-0212-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62111-0212-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62111-0212-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62111-0212-4	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62111-0212-4	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	62111-0212-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	62111-0212-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	62111-0212-4	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	62111-0212-4	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	62111-0212-4	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	62111-0212-4	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	62111-0212-4	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62111-0212-4	2019-11-27	C162847	48780-1	9855e2a2-3876-60a7-e053-dbdaa90a05bd	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62111-0212-4	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH	220 mL in 1 BOTTLE	MOUTHWASH	220		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
HYDROGEN PEROXIDE	INACTIVE INGREDIENT	BBX060AN9V	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
SALVADORA PERSICA ROOT	INACTIVE INGREDIENT	526M7ZU616	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1
ZINC LACTATE	INACTIVE INGREDIENT	2GXR25858Y	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62111-0212	PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]	1	Legacy NDC, 1 package rows	20140214_86d82d94-9439-4272-8ec2-8a014496d1bf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	86d82d94-9439-4272-8ec2-8a014496d1bf	1
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	86d82d94-9439-4272-8ec2-8a014496d1bf	1
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	86d82d94-9439-4272-8ec2-8a014496d1bf	1
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	86d82d94-9439-4272-8ec2-8a014496d1bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
62111-0212-4	62111021204	220 mL in 1 BOTTLE	220 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH	AKG Innovations LLC \| Wasatch Product Development LLC	2014-02-14	HUMAN OTC DRUG LABEL	1