SprinJene Natural

Product NDC: 63404-1984
11-digit product format: 634041984
Labeler code: 63404
Product ID: 63404-1984_4e23f203-d473-4e73-ab56-d9270e4c49e9
Type: HUMAN OTC DRUG
Nonproprietary name: Potassium Nitrate
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Health and Natural Beauty USA Corp
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-02-20
Substance: POTASSIUM NITRATE
Active strength: 50 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 26 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
2025-04-01 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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`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	63404-1984-1	`1332a3947898…`	`d4bfe170f9cd…`

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 and Gum
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
312544	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
3cb23e36-0e8c-4172-b4ae-859b58a2739f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63404-1984-1	2025-07-08	C162847	48780-1	f386c64a-3a0d-0266-e053-dadaa90a7c1a	SprinJene Natural ® Sensitivity & Gum
63404-1984-1	2023-01-30	C162847	48780-1	f386c64a-3a0d-0266-e053-dadaa90a7c1a	SprinJene Natural ® Sensitivity & Gum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63404-1984-1	SprinJene Natural Sensitivity and Gum	142 g in 1 TUBE	PASTE, DENTIFRICE	142		2
63404-1984-1	SprinJene Natural Sensitivity and Gum	1 in 1 CARTON	PASTE, DENTIFRICE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63404-1984	SPRINJENE NATURAL SENSITIVITY AND GUM (POTASSIUM NITRATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]	1	Current NDC, Legacy NDC, 2 package rows	20210220_3cb23e36-0e8c-4172-b4ae-859b58a2739f.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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitivity Relief Fluoride Free	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	c23b2a83-ebc3-4bcf-a216-7693944dcfa0	2026-05-22	Warnings	Exact identifier application number: M022
Sensitivity and Gum with Cavity Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Health and Natural Beauty USA Corp	137d6935-19a3-499d-957c-820156eec7a5	2026-05-22	Warnings	Exact identifier application number: M022
SEXYTEETH MINTY T00THPASTE	SEXYTEETH MINTY TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51d288c1-fe86-ffe1-e063-6394a90ab4c4	2026-05-14	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat cherry	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	2026-05-12	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat honey lemon	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	d771095b-7de3-48f3-a125-8bc76e7d1778	2026-05-12	Warnings	Exact identifier application number: M022
SEXYTEETH CHARCOAL T00THPASTE	SEXYTEETH CHARCOAL TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51ab8a9a-6c12-b13b-e063-6294a90ace2a	2026-05-12	Warnings	Exact identifier application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity	FLUORIDE	WHOLE FOODS	25bc7ab1-116d-143a-e063-6394a90aa970	2026-05-04	Warnings	Exact identifier application number: M022
Gingicaine Gel Strawberry	GINGICAINE GEL STRAWBERRY FLAVOR	Gingi-Pak a Division of the Belport	2fd37612-a28b-3aa1-e054-00144ff8d46c	2026-05-01	Warnings	Exact identifier application number: M022
3ECARE Dual formula WhiteningToothpaste Refill	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	501df1c7-4884-bb39-e063-6294a90aaf6a	2026-04-23	Warnings	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	1f10a72f-0b49-41cb-92f9-b0160d7664de	2026-04-22	Warnings	Exact identifier application number: M022
EverSmile AlignerFresh Enamel Guard	SODIUM FLUORIDE	Everbrands, Inc.	7b3d0114-dac0-4370-8545-922ec018018e	2026-04-21	Warnings	Exact identifier application number: M022
PREOP	HYDROGEN PEROXIDE	Everbrands, Inc.	cc5cdd29-92c1-4ce0-997e-eb624b288b09	2026-04-20	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	CVS	a7576238-e7c8-7e86-e053-2995a90aaeb5	2026-04-20	Warnings	Exact identifier application number: M022
CVS Pharmacy Maximum Strength	BENZOCAINE	CVS Pharmacy	92747826-cf58-4406-b3b5-12f7c7077c2c	2026-04-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	9f991292-bbaa-4f4e-b2cb-059d1a04849e	2026-04-20	Warnings	Exact identifier application number: M022
Osstem S Sensitivity relief tooth	POTASSIUM NITRATE, SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8ab179-8f29-a7cf-e063-6294a90a0c22	2026-04-15	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum DetoxifyWinter Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6db58f-0b09-d155-e063-6394a90ae658	2026-04-14	Warnings	Exact identifier application number: M022
Lolleez Orange Mango	PECTIN	BFY LLC	4f6dec8b-078a-f321-e063-6294a90a248c	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Restore Smooth Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6e3b36-e565-7d27-e063-6294a90ae5ac	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Nightly Bacteria Shield	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6ec1e0-c6b5-226f-e063-6294a90a8f14	2026-04-14	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312544	potassium nitrate 5 % Toothpaste	PSN	3cb23e36-0e8c-4172-b4ae-859b58a2739f	2
312544	potassium nitrate 0.05 MG/MG Toothpaste	SCD	3cb23e36-0e8c-4172-b4ae-859b58a2739f	2
312544	K+ nitrate 0.05 MG/MG Toothpaste	SY	3cb23e36-0e8c-4172-b4ae-859b58a2739f	2
312544	Pot nitrate 0.05 MG/MG Toothpaste	SY	3cb23e36-0e8c-4172-b4ae-859b58a2739f	2
312544	potassium nitrate 5 % Toothpaste	SY	3cb23e36-0e8c-4172-b4ae-859b58a2739f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63404-1984-1	63404198401	1 TUBE in 1 CARTON (63404-1984-1) / 142 g in 1 TUBE	1 tube	2021-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SprinJene Natural ® Sensitivity & Gum	Health and Natural Beauty USA Corp	2025-07-07	HUMAN OTC DRUG LABEL	2