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		2026-10-12
excluded package	package	83013-321	83013-321-01	D	Discontinued by firm		2026-10-12

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 24 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro Health Sensitive and Enamel Shield	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb48b15c-f821-e5cd-e053-6294a90ac64c	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Luminous Purple	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	fbfcd837-4d88-5f82-e053-6394a90afbf6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health with a Touch of Scope	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb572b41-36cd-55d7-e053-6394a90a71c8	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Whitening Gel	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb5b1e94-bed6-8486-e053-6294a90a3a84	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Ultra Vivid Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	cba96ef0-0519-059f-e053-2a95a90a43ad	2026-01-08	Warnings	Exact identifier application number: M021
Crest 4in1	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	ce545406-3c4f-1ba7-e053-2a95a90a91ac	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d218ddc0-1d5f-f39b-e053-2995a90a96ed	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Antibacterial Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d58bc842-2687-e52d-e053-2995a90a5433	2026-01-08	Warnings	Exact identifier application number: M021
Scope Stay Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d65b3153-2026-a8c0-e053-2a95a90a31d6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Whitening Charcoal	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d6f68485-b92f-41c7-e053-2995a90a4fe5	2026-01-08	Warnings	Exact identifier application number: M021
KIDS Crest Advanced Enamel Plus Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d837ecde-249a-7868-e053-2a95a90a56ae	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Whitening Intensive Cleaning	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d6fa4187-a651-647b-e053-2995a90a8567	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Gum Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d7729dde-c828-34e6-e053-2a95a90a5ee6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Densify Daily Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d811306f-4994-7a5a-e053-2995a90adf16	2026-01-08	Warnings	Exact identifier application number: M021
Crest Densify Daily Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d810d4e5-ba66-efe1-e053-2995a90abfc0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Braces Care Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d823cba4-c4cf-7d7a-e053-2995a90a01f0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Sensitive Relief	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d7730674-7513-52cf-e053-2995a90ab32c	2026-01-08	Warnings	Exact identifier application number: M021
Kids Crest Bubblegum Flavor	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	26a7a892-5da4-4749-bbb6-566efab7d749	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Plus Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	8c91095d-88c0-4d22-a79a-7d0f0d05302b	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Deep Clean Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d774295f-8ebd-9877-e053-2a95a90a9a0e	2026-01-08	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