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 39 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Pain Relief	BENZOCAINE	GERI-CARE PHARMACEUTICAL CORP	d294a39e-55f4-272d-e053-2995a90ab7f7	2023-10-31	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	e10c45e6-d37f-4650-b3e5-07719cc0ea49	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	886d949b-8db1-499c-a277-174f8bc29f34	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	fc8194af-2e77-4ad1-ae75-461dce3ed604	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	baf7d184-07ed-4491-a1fc-9a377b4b0110	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	033034af-c86c-4dbf-90eb-009c117024c6	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	658ada18-2334-4b4e-b08e-702fa127aa14	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	cad932e5-8d7f-4f20-b1c2-febd328152f0	2023-10-11	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	2c9519ab-320d-49da-9deb-97a6168fb088	2023-10-10	Warnings	Exact identifier application number: M022
Ioline	BENZOCAINE	Dharma Research, Inc.	b862c974-c024-42c3-986e-b65069437c7b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	651ea978-081d-4c59-b177-6049a69d9415	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	db763237-2910-45b9-be72-da092edc951b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	34316f93-10b4-41cc-8654-625283f0044c	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	142a8824-657e-492a-8e5a-b15eb73383c9	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	414cbec9-94e2-4bca-908b-1e79f8db0b27	2023-10-10	Warnings	Exact identifier application number: M022
Sore throat cherry	PHENOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de634cf1-ed39-4d8a-8855-006c69b7aee9	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	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