Hismile

Product NDC: 83013-327
11-digit product format: 830130327
Labeler code: 83013
Product ID: 83013-327_4879b95b-12f8-e9c9-e063-6294a90a9f28
Type: HUMAN OTC DRUG
Nonproprietary name: Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste
Dosage form: GEL
Route: DENTAL
Labeler: HISMILE PTY LTD
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-23
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	83013-327		D	Discontinued by firm	2026-10-12
excluded product	product	83013-327		D	Discontinued by firm	2026-10-12
excluded package	package	83013-327	83013-327-01	D	Discontinued by firm	2026-10-12
excluded package	package	83013-327	83013-327-02	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	83013-327-01	`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	83013-327-01	`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	83013-327-01	`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	83013-327-01	`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	83013-327-01	`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	83013-327-01	`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	83013-327-01	`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	83013-327-01	`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	83013-327-01	`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
1e725b7e-accc-f51c-e063-6394a90a455c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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
83013-327-06	Hismile	60 g in 1 BOTTLE, PUMP	GEL	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83013-327	HISMILE (CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE) GEL [HISMILE PTY LTD]	1	Current NDC, 1 package rows	20240731_1e725b7e-accc-f51c-e063-6394a90a455c.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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro Health Advanced Enamel Restore	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d813f5f0-3135-4a8f-e053-2a95a90a5562	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	8e189fbd-5094-4398-b96c-8f95d89b9cdd	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Densify Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d84fb9f9-f2bc-358a-e053-2995a90abf07	2026-01-08	Warnings	Exact identifier application number: M021
Kids Crest Strawberry Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	eb7a5698-754c-4e46-e053-2a95a90a57b4	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening System	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	89a6fb36-5109-47f1-95ad-9381471ceeef	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced w/Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	2c1c5563-0b7e-4c7c-b49f-3d72e078cd28	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Fresh Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c81ba39d-c7ea-b2a5-e053-2995a90a0fe7	2026-01-08		Exact identifier application number: M021
Crest Premium Plus Breath Bacteria Blast	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c3f1d477-6dd8-0ac4-e053-2a95a90a3742	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Active Foam Whitening scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c72b15e0-e69c-65fc-e053-2a95a90a54c8	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Plus Scope Outlast Ultra	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c3f63455-b09e-9877-e053-2a95a90a1844	2026-01-08	Warnings	Exact identifier application number: M021
Crest Tartar Protection Fresh Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	3d81d605-4f9b-3bb5-e054-00144ff88e88	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	e3b1f139-4fe8-f005-e053-2995a90a53b4	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Radiant Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f3dd7a34-a0d8-4ac6-bbd1-7c3b86187a57	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Plus Active Fresh plus Whitening Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c599d33f-788f-7fdd-e053-2a95a90a5f57	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi Benefit Whitening plus Scope Outlast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	66c41b24-d394-6609-e053-2a91aa0a0a2c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Plus 3 in 1	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b6fab2eb-da5c-749f-e053-2995a90a1357	2026-01-08	Warnings	Exact identifier application number: M021
Crest Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	85477763-1db5-482f-90e5-e71f5c1b4765	2026-01-08	Warnings	Exact identifier application number: M021
Crest Fresh and White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f9b31f6b-6b3f-abe0-e053-6294a90acb25	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c367c2cc-5e0f-bc4e-e053-2995a90a2e2c	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Glamorous White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c3f29f95-81b9-3989-e053-2a95a90af3a6	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	1e725b7e-accc-f51c-e063-6394a90a455c	2
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	1e725b7e-accc-f51c-e063-6394a90a455c	2
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	1e725b7e-accc-f51c-e063-6394a90a455c	2
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	1e725b7e-accc-f51c-e063-6394a90a455c	2
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	1e725b7e-accc-f51c-e063-6394a90a455c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83013-327-06	83013032706	60 g in 1 BOTTLE, PUMP (83013-327-06)	60 g	2024-07-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Candy Cane Flavor Sodium Fluoride Anticavity Toothpaste	HISMILE PTY LTD \| Accupac LLC	2026-01-15	HUMAN OTC DRUG LABEL	2
HISMILE - HISMILE PTY LTD	HISMILE PTY LTD	2024-09-10	HUMAN OTC DRUG LABEL	2