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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	b9e6e455-8444-4805-89f1-ee9142f98e36	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	7db8e49d-1073-4a81-a3a4-f3a19ebce921	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	1fe50b49-bc62-4137-866c-e87bb878a96d	2026-08-10	Warnings	Exact identifier application number: M021
Colgate Optic White Stain Fighter With Baking Soda	SODIUM FLUORIDE	Colgate-Palmolive Company	8e6113e2-101b-4bde-90e9-6ab32c6ebf5c	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH WATERMELON BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6c391ef3-d625-403c-a4dc-6e2212682ed1	2026-08-04	Warnings	Exact identifier application number: M021
Rorobell WaWa Tooth	SODIUM MONOFLUOROPHOSPHATE	ROROBELL	93113481-ad9d-4be0-a7b7-a72c8726127d	2026-08-03	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE CHARCOAL	SODIUM FLUORIDE	Colgate-Palmolive Company	70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2	2026-07-30	Warnings	Exact identifier application number: M021
Colgate Optic White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	82ac5b9d-19e8-46ac-a195-c7d85f2967d5	2026-07-30	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	251264ea-20d2-be19-e063-6394a90aa5f6	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Sensitive Enamel Guard Alpine Mint	SODIUM FLUORIDE	Lornamead Products	2e832204-ba2d-6dcb-e063-6394a90a5e6c	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Radiant White	FLUORIDE	Lornamead Products	f0b62aaa-4983-4bd3-931e-f1a31b870f62	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Stain Prevention	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	76df52a3-b24c-4009-8137-fe644dabebf6	2026-07-29	Warnings	Exact identifier application number: M021
Colgate Kids Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	f0e68196-8566-443b-9cc8-b57d5c001558	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Vividly Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f0551acf-c4d6-4d49-ae9c-4aeaeb99a700	2026-07-29	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Whitening KnockOut Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	92079d13-3b66-42b7-9990-2727a489b6f6	2026-07-28	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	7d04d050-b283-4fce-b1e9-e695b70363f9	2026-07-27	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd805999-86e4-4f6c-9889-fa9a2227d526	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	913a2cd6-b6a8-4069-979f-3c696a9bfdf0	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PURPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	16e9b303-fc2a-451a-adc7-dcb10fc0e6f8	2026-07-23	Warnings	Exact identifier application number: M021
Orajel Kids Superman	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	2b47af33-32d4-7c06-e063-6394a90a2f33	2026-07-23	Warnings	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