SprinJene Natural

Product NDC: 63404-1942
Requested package NDC: 63404-1942-1
11-digit product format: 634041942
Labeler code: 63404
Product ID: 63404-1942_8b20c8a1-ffe1-4f07-b783-b206720640c2
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate and Potassium Nitrate
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Health and Natural Beauty USA Corp
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-07-01
Substance: SODIUM MONOFLUOROPHOSPHATE; POTASSIUM NITRATE
Active strength: 1.5; 50 mg/g; 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 · 22 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	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 Natural
Brand name suffix: Sensitivity Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	1.5 mg/g
POTASSIUM NITRATE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C810JCZ56Q	Internal UNII lookup
RU45X2JN0Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038800	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
32cc5bc2-60c9-4cb4-acde-485ae494aba2	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63404-1942-1	2020-01-31	C162847	48780-1	9d75b9d0-b8a2-f424-e053-dadaa90a57ce	SprinJene ® Natural Sensitivity Relief
63404-1942-1	2020-01-31	C162847	48780-1	9d75b9d0-b8a2-f424-e053-dadaa90a57ce	SprinJene ® Natural Sensitivity Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63404-1942-1	SprinJene Natural Sensitivity Relief	99 g in 1 TUBE	PASTE, DENTIFRICE	99		1
63404-1942-1	SprinJene Natural Sensitivity Relief	1 in 1 CARTON	PASTE, DENTIFRICE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63404-1942	SPRINJENE NATURAL SENSITIVITY RELIEF (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	1	Current NDC, Legacy NDC, 2 package rows	20170909_32cc5bc2-60c9-4cb4-acde-485ae494aba2.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
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE

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	32cc5bc2-60c9-4cb4-acde-485ae494aba2	1
1038800	potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG Toothpaste	SCD	32cc5bc2-60c9-4cb4-acde-485ae494aba2	1
1038800	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste	SY	32cc5bc2-60c9-4cb4-acde-485ae494aba2	1
1038800	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste	SY	32cc5bc2-60c9-4cb4-acde-485ae494aba2	1
1038800	potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	32cc5bc2-60c9-4cb4-acde-485ae494aba2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63404-1942-1	63404194201	1 TUBE in 1 CARTON (63404-1942-1) / 99 g in 1 TUBE	1 tube	2017-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SprinJene ® Natural Sensitivity Relief	Health and Natural Beauty USA Corp	2026-08-14	HUMAN OTC DRUG LABEL	2