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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Kids Space Jam Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	54cbfb09-8fd7-ef08-99fd-14fc019c81ff	2024-11-14	Warnings	Exact identifier application number: M021
Colgate Kids Llama Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive	a7b02cb2-cfb3-7b35-42da-7924d156dcc3	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	82bc1101-84d7-4e21-be9c-870ad88a4b7c	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	COLGATE PALMOLIVE COMPANY	b6ca4ec7-5087-4693-82b7-199b44d7f931	2024-11-13	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Clinical Solutions Teeth Strength Alpine Mint	SODIUM FLUORIDE	Kenvue Brands LLC	06e2de03-4a58-3de0-e063-6294a90a5857	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	ee9a962d-83c7-4b13-bff6-140e48785e8a	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield	SODIUM FLUORIDE	Kenvue Brands LLC	d69d2e0d-a3e3-4d95-992d-c0c59172b3a5	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast	SODIUM FLUORIDE	Kenvue Brands LLC	f09f334b-709c-473e-b91e-3f31480ceb90	2024-11-11	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	LG H&H Co.,Ltd.	2697fa68-b991-ab09-e063-6394a90aec4c	2024-11-01	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	Tai Guk Pharma. Co., Ltd.	2698d6d8-051b-6c10-e063-6394a90a9418	2024-11-01	Warnings	Exact identifier application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)	SODIUM FLUORIDE	MADE BY DENTISTS INC	263c448b-728f-4370-bcdb-148d614d9b34	2024-10-30	Warnings	Exact identifier application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	17f589e9-f4ba-46d3-a345-db38f9a9067d	2024-10-17	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Wild Watermelon	SODIUM FLUORIDE	Chattem, Inc.	8d7faeab-ac70-472a-acbb-de67493718ce	2024-10-16	Warnings	Exact identifier application number: M021
Rexall Restore and Defend Sensitive Whitening	STANNOUS FLUORIDE	Old East Main CO.	691c9638-75d2-4e53-bec4-2eafacd7216c	2024-10-14	Warnings	Exact identifier application number: M021
Rexall Travel Toothbrush and Tooth-paste	SODIUM MONOFLUOROPHOSPHATE	Old East Main CO.	1bfba18b-1418-4c39-b666-96fa0674cc70	2024-10-14	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Navajo Manufacturing Company Inc.	23851360-e30e-dd97-e063-6394a90a5474	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	36cd9cfc-7390-4400-8ede-b9d172d83953	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	85e83b72-2d09-aec0-db7e-6b5715c5a86c	2024-10-01	Warnings	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