SprinJene

Product NDC: 63404-1116
11-digit product format: 634041116
Labeler code: 63404
Product ID: 63404-1116_b7ffb349-2a06-4ff7-b8bc-0c9975b47c83
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Health and Natural Beauty USA Corp
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-10
Substance: SODIUM FLUORIDE
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 2 · 66 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	63404-1116-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63404-1116-1	`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	63404-1116-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63404-1116-1	`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	63404-1116-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63404-1116-1	`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	63404-1116-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63404-1116-1	`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	63404-1116-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63404-1116-1	`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	63404-1116-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63404-1116-1	`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	63404-1116-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63404-1116-1	`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	63404-1116-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63404-1116-1	`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	63404-1116-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63404-1116-1	`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	63404-1116-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63404-1116-1	`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	63404-1116-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63404-1116-1	`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	63404-1116-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63404-1116-1	`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	63404-1116-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63404-1116-1	`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	63404-1116-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63404-1116-1	`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	63404-1116-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63404-1116-1	`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	63404-1116-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63404-1116-2	`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	63404-1116-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63404-1116-2	`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	63404-1116-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63404-1116-2	`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	63404-1116-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63404-1116-2	`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	63404-1116-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63404-1116-2	`e2bbac7714bc…`	`27bdfed8d636…`

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: White Boost
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	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
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
891775	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
8c401bea-0148-46a0-bbb3-80c17f9e8e3e	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
63404-1116-1	SprinJene™ White Boost
63404-1116-1	SprinJene™ White Boost
63404-1116-2	SprinJene™ White Boost
63404-1116-2	SprinJene™ White Boost

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63404-1116-1	SprinJene White Boost	1 in 1 CARTON	PASTE, DENTIFRICE	1	3
63404-1116-1	SprinJene White Boost	142 g in 1 TUBE	PASTE, DENTIFRICE	142	3
63404-1116-2	SprinJene White Boost	1 in 1 CARTON	PASTE, DENTIFRICE	1	3
63404-1116-2	SprinJene White Boost	42 g in 1 TUBE	PASTE, DENTIFRICE	42	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Guizotia Abyssinica Seed Oil	INACTIVE INGREDIENT	QX0GL46299	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Sodium Pyrophosphate	INACTIVE INGREDIENT	O352864B8Z	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Sorbitol	INACTIVE INGREDIENT	506T60A25R	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Zinc Citrate	INACTIVE INGREDIENT	K72I3DEX9B	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3
Zinc Oxide	INACTIVE INGREDIENT	SOI2LOH54Z	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63404-1116	SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	3	Current NDC, Legacy NDC, 4 package rows	20150213_8c401bea-0148-46a0-bbb3-80c17f9e8e3e.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT	SODIUM FLUORIDE	Colgate-Palmolive Company	b1ef8277-9919-453c-9d21-da4666d952de	2026-09-17	Warnings	Exact identifier application number: M021
TheraBreath	SODIUM FLUORIDE	Church & Dwight Co., Inc.	53c1086d-264b-9d00-e063-6394a90ad19d	2026-09-09	Warnings	Exact identifier application number: M021
Opalescence Whitening Cool Mint	SODIUM FLUORIDE	Ultradent Products, Inc.	44e7d0ed-3c37-5889-e063-6294a90afcca	2026-09-09	Warnings	Exact identifier application number: M021
Opalescence Whitening	SODIUM FLUORIDE	Ultradent Products, Inc	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	2026-09-09	Warnings	Exact identifier application number: M021
Opal by Opalescence Original	SODIUM FLUORIDE	Ultradent Products, Inc.	5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	2026-09-09	Warnings	Exact identifier application number: M021
Opal by Opalescence Complete	OPAL BY OPALESCENCE COMPLETE	Ultradent Products, Inc.	249cc46a-dad6-0345-e063-6394a90a4447	2026-09-09	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	Colgate-Palmolive Company	0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9	2026-09-09	Warnings	Exact identifier application number: M021
Colgate MaxFresh Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	de3674f4-3ce6-47d5-8391-6ad6789d68d9	2026-09-09	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity	SODIUM FLUORIDE	New World Imports, Inc	ef108fff-a79c-4e8d-8bf0-3fe567f93eb8	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity	SODIUM FLUORIDE	New World Imports, Inc	1a42cf2d-6c48-4e38-97bc-b6f2084bf39b	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity Gel	SODIUM FLUORIDE	New World Imports, Inc	dfe564c1-2097-431d-93f0-cf423f254248	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	New World Imports, Inc	5aff7e41-58cd-5ab8-e063-6294a90aa1c7	2026-09-08	Warnings	Exact identifier application number: M021
Colgate Optic White Advanced Sparkling White	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	bc56603d-4190-48c1-b16e-3179a650cb39	2026-09-06	Warnings	Exact identifier application number: M021
Dentalclean Advanced Pro	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	4d261dc8-b065-567f-e063-6294a90aa93f	2026-09-04	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	54bd43c9-489d-4e6b-9031-90ec0e3c4516	2026-09-01	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	53c344e9-49f5-48aa-8309-1e15f80b80a0	2026-09-01	Warnings	Exact identifier application number: M021
Unpaste	ZERO WASTE FLUORIDE MINT TOOTH TABS	Avespan LLC	312ae88d-7ea4-b3e0-e063-6294a90a99e5	2026-09-01	Warnings	Exact identifier application number: M021
Dentalclean Regenerator Sensitive Dental Gel with Fluoride	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	176aa3ed-e2a4-536d-e063-6294a90aa097	2026-08-31	Warnings	Exact identifier application number: M021
Listerine Total Care Fresh Mint Anticavity	SODIUM FLUORIDE	Kenvue Brands LLC	b2ce66c3-dc48-47a5-a731-5550bc194679	2026-08-28	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Your Military Exchanges	cef74e9c-d3b5-4e92-9908-187be97b63ab	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M021

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
891775	sodium fluoride 0.243 % Toothpaste	PSN	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	3
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	3
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	3
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	3
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	3
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63404-1116-1	63404111601	1 TUBE in 1 CARTON (63404-1116-1) / 142 g in 1 TUBE	1 tube	2014-10-10	No	No	Current
63404-1116-2	63404111602	1 TUBE in 1 CARTON (63404-1116-2) / 42 g in 1 TUBE	1 tube	2014-10-10	No	No	Current
63404-1116-3	63404111603	1 TUBE in 1 CARTON (63404-1116-3) / 75 g in 1 TUBE	1 tube	2026-01-01	No	No	Current