BeanGuard Sensitivetoothpaste

Product NDC: 77935-401
Requested package NDC: 77935-401-01
11-digit product format: 779350401
Labeler code: 77935
Product ID: 77935-401_f0669f7c-b12c-6015-e053-2995a90aae3c
Type: HUMAN OTC DRUG
Nonproprietary name: HYDRATED SILICA, POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: BIO3S Co.,Ltd.
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2022-12-27
Marketing end: 0000-00-00
Substance: HYDRATED SILICA; POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 18 g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	77935-401	77935-401-01	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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77935-401-01	2024-01-30	C162847	48780-1	1030e365-627b-111a-e063-dadaa90a10e2	77935-401 BeanGuard Sensitive toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77935-401-01	BeanGuard Sensitivetoothpaste	120 mL in 1 TUBE	PASTE, DENTIFRICE	120		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77935-401	BEANGUARD SENSITIVETOOTHPASTE (HYDRATED SILICA, POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BIO3S CO.,LTD.]	1	Legacy NDC, 1 package rows	20221229_f0669f7c-b12b-6015-e053-2995a90aae3c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y6O7T4G8P9	HYDRATED SILICA	1343-98-2	HYDRATED SILICA
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77935-401-01	77935040101	120 mL in 1 TUBE (77935-401-01)	120 ml	2022-12-27	0000-00-00	No	No	Current