Primo APF

Product NDC: 69509-054
11-digit product format: 695090054
Labeler code: 69509
Product ID: 69509-054_d607ffd6-fb16-35ba-e053-2995a90abc1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL
Route: DENTAL
Labeler: Tri State Dental
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2013-09-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 6 g/454g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69509-054		I	Inactivated by FDA		2026-09-09
excluded package	package	69509-054	69509-054-15	I	Inactivated by FDA		2026-09-09

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69509-054-15	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69509-054-15	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69509-054-15	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69509-054-15	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69509-054-15	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69509-054-15	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69509-054-15	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69509-054-15	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69509-054-15	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69509-054-15	2025-01-30	C162847	48780-1	2cef2736-82a1-d83d-e063-dadaa90ab31f	c060aaef-d2e9-4acf-ac27-b30796239a8f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69509-054-15	Primo APF	454 g in 1 BOTTLE, PLASTIC	GEL	454		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Magnesium Aluminum Silicate	INACTIVE INGREDIENT	6M3P64V0NC	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Phosphoric Acid	INACTIVE INGREDIENT	E4GA8884NN	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69509-054	PRIMO APF (SODIUM FLUORIDE) GEL [TRI STATE DENTAL]	3	Legacy NDC, 1 package rows	20220121_c060aaef-d2e9-4acf-ac27-b30796239a8f.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
245593	sodium fluoride 2 % Dental Gel	PSN	c060aaef-d2e9-4acf-ac27-b30796239a8f	3
245593	sodium fluoride 0.02 MG/MG Oral Gel	SCD	c060aaef-d2e9-4acf-ac27-b30796239a8f	3
245593	sodium fluoride 2 % (fluoride ion 1.23 % ) Dental Gel	SY	c060aaef-d2e9-4acf-ac27-b30796239a8f	3
245593	sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental Gel	SY	c060aaef-d2e9-4acf-ac27-b30796239a8f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69509-054-15	69509005415	454 g in 1 BOTTLE, PLASTIC (69509-054-15)	454 g	2013-09-01	0000-00-00	No	No	Current