HISMILE

Product NDC: 83013-321
11-digit product format: 830130321
Labeler code: 83013
Product ID: 83013-321_4878f152-3d7a-8458-e063-6394a90a7478
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL
Route: DENTAL
Labeler: HISMILE PTY LTD
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-15
Substance: SODIUM FLUORIDE
Active strength: .243 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	83013-321		D	Discontinued by firm		2026-10-05
excluded package	package	83013-321	83013-321-01	D	Discontinued by firm		2026-10-05

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 · 18 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	83013-321-01	`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	83013-321-01	`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	83013-321-01	`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	83013-321-01	`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	83013-321-01	`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	83013-321-01	`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	83013-321-01	`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	83013-321-01	`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	83013-321-01	`0efc9e666f02…`	`f202fb6c5f17…`

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: HISMILE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.243 g/100g

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
416783	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
1d40b98b-2e9a-d84a-e063-6294a90a2096	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83013-321-06	HISMILE	60 g in 1 BOTTLE, PUMP	GEL	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83013-321	HISMILE (SODIUM FLUORIDE) GEL [HISMILE PTY LTD]	2	Current NDC, 1 package rows	20240724_1d40b98b-2e9a-d84a-e063-6294a90a2096.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 3 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SprinJene Fresh Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	919f6f51-6c43-4f1c-9bc7-029bf76c0e68	2026-08-14	Warnings	Exact identifier application number: M021
SprinJene Natural Sensitivity Relief	SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE	Health and Natural Beauty USA Corp	32cc5bc2-60c9-4cb4-acde-485ae494aba2	2026-08-14	Warnings	Exact identifier application number: M021
SprinJene White Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	2026-08-14	Warnings	Exact identifier application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	2b123d70-4f7d-41b0-b48f-711999e97ee0	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE STRAWBERRY BURST	SODIUM FLUORIDE	Colgate-Palmolive Company	d037f65c-3d22-4d2a-a0a9-3dcba2357ebd	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd954777-697a-4cc7-8f5f-b2caf357ef95	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRY	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	e36ceb7a-9a29-41d8-8d08-a859e515f1f5	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	08d7ed04-67a4-437a-82c5-496f9893c6c7	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	27278b02-c4fd-4092-a632-a14e442f5a95	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICE	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	59a6b9ac-c28b-4ec3-8231-f35054ce0eaf	2026-08-10	Warnings	Exact identifier application number: M021
Toms Kids Watermelon Wiggle	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	64b60e74-fceb-4de9-a966-73bf8dbd666c	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	7e880d50-8aab-4d57-abc1-e900070f9a11	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	5cb5eb46-705c-4bb7-bef1-e93a598636fd	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	0e043431-9d87-478d-87f5-5aa8b0a932eb	2026-08-10	Warnings	Exact identifier application number: M021
Willo Minty Mist Dye Free	SODIUM FLUORIDE	Willo 32, Inc.	3ee5b49e-ca9a-ece6-e063-6394a90a3d00	2026-08-10	Warnings	Exact identifier application number: M021
Willo Bubble Twist	SODIUM FLUORIDE	Willo 32 Inc	36560d62-e901-1f93-e063-6394a90a2803	2026-08-10	Warnings	Exact identifier application number: M021
Willo Berry Splash Dye Free	SODIUM FLUORIDE	Willo 32, Inc	3ea91af9-2895-e530-e063-6394a90a39e5	2026-08-10	Warnings	Exact identifier application number: M021
Fluoride Mouth Rinse Anticavity	SODIUM FLUORIDE	Target Corporation	3daf3cc3-585a-4bb2-9b56-7117d220ed38	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	19de1e71-ab94-415f-b66d-e5748dea8317	2026-08-10	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
416783	sodium fluoride 0.24 % Toothpaste	PSN	1d40b98b-2e9a-d84a-e063-6294a90a2096	3
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	1d40b98b-2e9a-d84a-e063-6294a90a2096	3
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	1d40b98b-2e9a-d84a-e063-6294a90a2096	3
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	1d40b98b-2e9a-d84a-e063-6294a90a2096	3
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	1d40b98b-2e9a-d84a-e063-6294a90a2096	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83013-321-06	83013032106	60 g in 1 BOTTLE, PUMP (83013-321-06)	60 g	2024-07-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cherry Flavor Sodium Fluoride Anticavity Toothpaste	HISMILE PTY LTD \| Accupac LLC	2026-01-15	HUMAN OTC DRUG LABEL	3
HISMILE - HISMILE PTY LTD \| Accupac LLC	HISMILE PTY LTD \| Accupac LLC	2024-07-30	HUMAN OTC DRUG LABEL	1