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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CloSYS	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	ed617c7a-805c-4788-9bce-9b7fead4312d	2026-03-31	Warnings	Exact identifier application number: M021
Colgate Total Enamel Strength	STANNOUS FLUORIDE	Colgate-Palmolive Company	1f29c893-e7c5-4a0e-941b-c2634d821147	2026-03-25	Warnings	Exact identifier application number: M021
AP-24 Whitening	SODIUM MONOFLUOROPHOSPHATE	NSE Products, Inc.	57e9e68c-41dd-470b-80db-dfaedc0e2a0a	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369c0d44-6375-dcae-e063-6394a90a74d0	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369bc785-fb77-a56d-e063-6394a90a2e6b	2026-03-24	Warnings	Exact identifier application number: M021
SensitiveToothpaste	ANTI SENSITIVETOOTHPASTE	Huain Best Trade Co., Ltd.	4db239f3-2ad7-3a5b-e063-6294a90a11a7	2026-03-23	Warnings	Exact identifier application number: M021
Crest Bubblegum	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d6268c7-b273-1bbf-e053-2a91aa0a5d32	2026-03-17	Warnings	Exact identifier application number: M021
Natures Promise Childrens Fluoride Strawberry	SODIUM MONOFLUOROPHOSPHATE	Foodhold U.S.A.	81a4e196-8b2d-0745-e053-2991aa0a7de6	2026-03-16	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae8badf-f960-62fd-e054-00144ff8d46c	2026-03-11	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae71258-a8c2-6eb5-e054-00144ff88e88	2026-03-11	Warnings	Exact identifier application number: M021
Delta Travel Kit Comfort plus	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	d31e0920-4317-1e0c-e053-2a95a90aebeb	2026-03-11	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	CVS Pharmacy, Inc.	eac346d9-d9c1-4417-8193-390c7a0dcc2a	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6caf3f2e-70a2-4530-99fa-f5af7e4c511a	2026-03-10	Warnings	Exact identifier application number: M021
Amerfresh Toothpowder	SODIUM FLUORIDE	Yangzhou ONE & ONLY Personal Care Products Co., LTD	1cacf93e-aa60-4717-87ab-0568a701a4f3	2026-03-10	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	CVS Pharmacy, Inc.	a51357df-6d55-4030-a5db-42da7ba54a37	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M021
Fluoride	FLUORIDE TOOTHPASTE	McKesson	4c482e45-0502-a93a-e063-6394a90aa961	2026-03-05	Warnings	Exact identifier application number: M021
Colgate Maximum Cavity Protection Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	0a1389f6-cac9-3d58-0744-c488abb0bbcc	2026-03-03	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Amazon.com Services LLC	349eca80-2e0c-409b-af29-3235fdc0695b	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Amazon.com Services LLC	03735abc-d1be-4ca0-a497-0a5c5f289402	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Old East Main Co.	f8036e2e-7541-4922-92b9-0d8319f7b64c	2026-03-02	Warnings, Adverse reactions	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