SprinJene

Product NDC: 63404-1108
11-digit product format: 634041108
Labeler code: 63404
Product ID: 63404-1108_2c7c212f-b7da-47a0-bbfb-73fd530e252a
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Health and Natural Beauty USA Corp
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-07-01
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 1.5 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 48 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	63404-1108-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63404-1108-2	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	63404-1108-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63404-1108-2	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	63404-1108-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63404-1108-2	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	63404-1108-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63404-1108-2	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	63404-1108-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63404-1108-2	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	63404-1108-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63404-1108-2	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	63404-1108-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63404-1108-2	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	63404-1108-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63404-1108-2	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	63404-1108-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63404-1108-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63404-1108-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63404-1108-2	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63404-1108-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63404-1108-2	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63404-1108-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63404-1108-2	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63404-1108-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63404-1108-2	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63404-1108-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63404-1108-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63404-1108-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63404-1108-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63404-1108-2	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63404-1108-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: SprinJene
Brand name suffix: Health Boost
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C810JCZ56Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
545626	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9be87bcd-403a-4d7e-8ded-9833249565d1	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63404-1108-1	2025-01-30	SprinJene ® Health Boost
63404-1108-1	2025-01-30	SprinJene ® SprinJene ® Health Boost Gel
63404-1108-2	2025-01-30	SprinJene ® Health Boost
63404-1108-2	2025-01-30	SprinJene ® SprinJene ® Health Boost Gel
63404-1108-1	2023-02-22	SprinJene ® Health Boost
63404-1108-1	2023-02-22	SprinJene ® SprinJene ® Health Boost Gel
63404-1108-2	2023-02-22	SprinJene ® Health Boost
63404-1108-2	2023-02-22	SprinJene ® SprinJene ® Health Boost Gel
63404-1108-1	2020-01-31	SprinJene ® Health Boost
63404-1108-1	2020-01-31	SprinJene ® SprinJene ® Health Boost Gel
63404-1108-2	2020-01-31	SprinJene ® Health Boost
63404-1108-2	2020-01-31	SprinJene ® SprinJene ® Health Boost Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63404-1108-1	SprinJene Health Boost	142 g in 1 TUBE	PASTE, DENTIFRICE	142	3
63404-1108-1	SprinJene Health Boost	1 in 1 CARTON	PASTE, DENTIFRICE	1	3
63404-1108-2	SprinJene Health Boost	42 g in 1 TUBE	PASTE, DENTIFRICE	42	3
63404-1108-2	SprinJene Health Boost	1 in 1 CARTON	PASTE, DENTIFRICE	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63404-1108	SPRINJENE HEALTH BOOST (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3	Current NDC, Legacy NDC, 4 package rows	20230223_9be87bcd-403a-4d7e-8ded-9833249565d1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Frida Fluoride Sweet Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b5a39-5d79-72cd-e063-6394a90a475c	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Bubble Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b9af3-e4b3-b5e0-e063-6394a90a1068	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry Toothbrush Set	SODIUM FLUORIDE	Fridababy, LLC	4f8ba14f-60ea-c2a8-e063-6394a90a7702	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry	SODIUM FLUORIDE	Fridababy, LLC	4f814a62-8f91-8ea6-e063-6294a90a69eb	2026-05-06	Warnings	Exact identifier application number: M021
Gum Health Detoxify	STANNOUS FLUORIDE	Meijer, Inc	41d70733-a223-40fb-e063-6294a90a1397	2026-05-06	Warnings	Exact identifier application number: M021
Colgate Kids Unicorn Alcohol Free	SODIUM FLUORIDE	Colgate-Palmolive Company	133acaff-7205-80d7-e91d-3eb37087cae4	2026-05-05	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	fdefffbd-9c05-fa30-e053-6394a90a34bc	2026-05-05	Warnings	Exact identifier application number: M021
Frida Fluoride Watermelon	SODIUM FLUORIDE	Fridababy, LLC	4f8b49dc-e9e4-c341-e063-6294a90adb5a	2026-05-05	Warnings	Exact identifier application number: M021
White Glo Extreme White Whitening	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	4a2e0a8d-420e-4c07-aa43-386d05dab472	2026-04-30	Warnings	Exact identifier application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TP	STANNOUS FLUORIDE	Walmart Inc.	1e6561fb-4e3b-40ba-e063-6294a90a2690	2026-04-29	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	852889b4-59ba-4592-b4fc-c0127a1ad075	2026-04-28	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Scope	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	0206710a-707f-4aa9-96b9-86240c1275dc	2026-04-28	Warnings	Exact identifier application number: M021
Alcohol Free Refreshing Mint	SODIUM FLUORIDE	H E B	cedf7c08-7412-4733-9b67-225b331cec8c	2026-04-27	Warnings, Adverse reactions	Exact identifier application number: M021
anzoon ANTIBACTERIAL MOUTH WASH	CETYLPYRIDINIUM CHLORIDE	Shandong AZC Biotechnology Co.,Ltd.	507c6896-2806-790c-e063-6394a90ac5ce	2026-04-27	Warnings	Exact identifier application number: M021
DELTA COMFORT PLUS AMENITY	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	26434794-ae02-0f58-e063-6294a90ad85e	2026-04-24	Warnings	Exact identifier application number: M021
A and H Plus Therabreath Breath Freshners	SODIUM FLUORIDE	Church & Dwight Co., Inc.	18d6073e-b1ee-47d2-9758-2cf04f3cf3ca	2026-04-23	Warnings	Exact identifier application number: M021
Fluoride	SODIUM FLUORIDE	McKesson	5025e58e-e59c-07b6-e063-6394a90ac1e8	2026-04-23	Warnings	Exact identifier application number: M021
PRO-SYS	SENSITIVITY - MINT (OTC)	Benco Dental	4e46847e-8c1d-c988-e063-6394a90a8e50	2026-04-22	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	87327a36-a314-4daa-83b6-b4bd3e26bba2	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	8df324a7-9204-40f3-8ddb-1656286d7d4e	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: M021

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	9be87bcd-403a-4d7e-8ded-9833249565d1	3
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	9be87bcd-403a-4d7e-8ded-9833249565d1	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	9be87bcd-403a-4d7e-8ded-9833249565d1	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	9be87bcd-403a-4d7e-8ded-9833249565d1	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	9be87bcd-403a-4d7e-8ded-9833249565d1	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	9be87bcd-403a-4d7e-8ded-9833249565d1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63404-1108-1	63404110801	1 TUBE in 1 CARTON (63404-1108-1) / 142 g in 1 TUBE	1 tube	2016-07-01	No	No	Current
63404-1108-2	63404110802	1 TUBE in 1 CARTON (63404-1108-2) / 42 g in 1 TUBE	1 tube	2016-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SprinJene ® SprinJene ® Health Boost Gel	Health and Natural Beauty USA Corp	2026-08-14	HUMAN OTC DRUG LABEL	4