VVARDIS SET SOFT MINT

Product NDC: 79763-004
Requested package NDC: 79763-004-01
11-digit product format: 797630004
Labeler code: 79763
Product ID: 79763-004_c9ee4e8d-d528-9960-e053-2995a90a29bc
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride, Sodium Monofluorophosphate
Dosage form: KIT
Route: ORAL
Labeler: Swiss Shine Beauty AG
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-07-22
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	79763-004	79763-004-01	I	Inactivated by FDA		2026-10-05

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 · 15 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79763-004-01	2023-01-30	C162847	48780-1	f386c649-9b84-0266-e053-dadaa90a7c1a	VVARDIS SET SOFT MINT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79763-004-01	VVARDIS SET SOFT MINT	1 in 1 KIT	KIT	1		2
79763-005-01	VVARDIS SET SOFT MINT	100 mL in 1 BOTTLE	MOUTHWASH	100 mL	0.05 g in 100mL	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79763-004	VVARDIS SET SOFT MINT (SODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE) KIT [SWISS SHINE BEAUTY AG]	2	Legacy NDC, 2 package rows	20210820_ab0ef0ce-e6a8-2707-e053-2995a90aef43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	ab0ef0ce-e6a8-2707-e053-2995a90aef43	2
1546238	sodium monofluorophosphate 0.88 % Toothpaste	PSN	ab0ef0ce-e6a8-2707-e053-2995a90aef43	2
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	ab0ef0ce-e6a8-2707-e053-2995a90aef43	2
1546238	sodium monofluorophosphate 0.0088 MG/MG Toothpaste	SCD	ab0ef0ce-e6a8-2707-e053-2995a90aef43	2
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	ab0ef0ce-e6a8-2707-e053-2995a90aef43	2
1546238	sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )Toothpaste	SY	ab0ef0ce-e6a8-2707-e053-2995a90aef43	2
1546238	sodium monofluorophosphate 0.88 % Toothpaste	SY	ab0ef0ce-e6a8-2707-e053-2995a90aef43	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79763-004-01	79763000401	1 KIT in 1 KIT (79763-004-01) * 65 g in 1 TUBE (79763-006-01) * 2.6 g in 1 BOTTLE, WITH APPLICATOR * 100 mL in 1 BOTTLE (79763-005-01)	1 kit	2020-07-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VVARDIS SET SOFT MINT	Swiss Shine Beauty AG \| System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH \| Marvinpac SA	2021-08-19	HUMAN OTC DRUG LABEL	2