PremierPro Fluoride Tooth

Product NDC: 69392-001
11-digit product format: 693920001
Labeler code: 69392
Product ID: 69392-001_946328f8-56db-4928-b767-30f65e8114fc
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: SVS, LLC (DBA S2S Global)
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 0 g/100g
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69392-001		I	Inactivated by FDA	2026-10-05
excluded package	package	69392-001	69392-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	69392-001	69392-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	69392-001	69392-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	69392-001	69392-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	69392-001	69392-001-05	I	Inactivated by FDA	2026-10-05
excluded package	package	69392-001	69392-001-06	I	Inactivated by FDA	2026-10-05
excluded package	package	69392-001	69392-001-07	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 3 · 176 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	69392-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69392-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69392-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69392-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69392-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69392-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69392-001-06	`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	69392-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69392-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69392-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69392-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69392-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69392-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69392-001-06	`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	69392-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69392-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69392-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69392-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69392-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69392-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69392-001-06	`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	69392-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69392-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69392-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69392-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69392-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69392-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69392-001-06	`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	69392-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69392-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69392-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69392-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69392-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69392-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69392-001-06	`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	69392-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69392-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69392-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69392-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69392-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69392-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69392-001-06	`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	69392-001-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69392-001-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69392-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69392-001-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69392-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69392-001-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69392-001-06	`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	69392-001-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69392-001-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69392-001-02	`ed331223b511…`	`672a5bd82f5f…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
69392-001-01	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-02	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-03	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-04	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-05	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-06	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-07	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69392-001-01	PremierPro Fluoride Tooth	14 g in 1 TUBE	PASTE, DENTIFRICE	14	2
69392-001-02	PremierPro Fluoride Tooth	24 g in 1 TUBE	PASTE, DENTIFRICE	24	2
69392-001-03	PremierPro Fluoride Tooth	42 g in 1 TUBE	PASTE, DENTIFRICE	42	2
69392-001-04	PremierPro Fluoride Tooth	78 g in 1 TUBE	PASTE, DENTIFRICE	78	2
69392-001-05	PremierPro Fluoride Tooth	85 g in 1 TUBE	PASTE, DENTIFRICE	85	2
69392-001-06	PremierPro Fluoride Tooth	130 g in 1 TUBE	PASTE, DENTIFRICE	130	2
69392-001-07	PremierPro Fluoride Tooth	198 g in 1 TUBE	PASTE, DENTIFRICE	198	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)	INACTIVE INGREDIENT	99H65D77XY	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69392-001	PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]	2	Legacy NDC, 7 package rows	20150120_7faa8f2c-c583-4a3a-9fd7-c48a439bce5d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d	2
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	7faa8f2c-c583-4a3a-9fd7-c48a439bce5d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69392-001-01	69392000101	14 g in 1 TUBE	14 g	Historical
69392-001-02	69392000102	24 g in 1 TUBE	24 g	Historical
69392-001-03	69392000103	42 g in 1 TUBE	42 g	Historical
69392-001-04	69392000104	78 g in 1 TUBE	78 g	Historical
69392-001-05	69392000105	85 g in 1 TUBE	85 g	Historical
69392-001-06	69392000106	130 g in 1 TUBE	130 g	Historical
69392-001-07	69392000107	198 g in 1 TUBE	198 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PremierPro Fluoride Tooth - SVS, LLC (DBA S2S Global)	SVS, LLC (DBA S2S Global)	2015-01-19	HUMAN OTC DRUG LABEL	2