Family Wellness Sensitive Extra Whitening

Product NDC: 55319-900
11-digit product format: 553190900
Labeler code: 55319
Product ID: 55319-900_f06fee99-2d1b-4adf-a5a0-9e90db64a461
Type: HUMAN OTC DRUG
Nonproprietary name: Potassium Nitrate and Sodium Fluoride
Dosage form: PASTE
Route: DENTAL
Labeler: Family Wellness
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-04-11
Marketing end: 0000-00-00
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 5 mg/g; mg/g
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	55319-900		I	Inactivated by FDA		2026-10-05
excluded package	package	55319-900	55319-900-01	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 · 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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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	55319-900-01	`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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-900-01	2019-11-27	C162847	48780-1	9855d018-eab3-cd31-e053-dbdaa90ab51a	Family Wellness Sensitive Extra Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-900-01	Family Wellness Sensitive Extra Whitening	113 g in 1 TUBE	PASTE	113		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM NITRATE	ACTIVE INGREDIENT	RU45X2JN0Z	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-900	FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]	1	Legacy NDC, 1 package rows	20130423_22b5d423-b43a-4be9-be98-998640ff1c13.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038800	potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) Toothpaste	PSN	22b5d423-b43a-4be9-be98-998640ff1c13	1
1038800	potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG Toothpaste	SCD	22b5d423-b43a-4be9-be98-998640ff1c13	1
1038800	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste	SY	22b5d423-b43a-4be9-be98-998640ff1c13	1
1038800	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste	SY	22b5d423-b43a-4be9-be98-998640ff1c13	1
1038800	potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	22b5d423-b43a-4be9-be98-998640ff1c13	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55319-900-01	55319090001	113 g in 1 TUBE	113 g	Historical