Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast

Product NDC: 83013-331
11-digit product format: 830130331
Labeler code: 83013
Product ID: 83013-331_3033b314-4dc3-d60c-e063-6394a90a1f9b
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium fluoride
Dosage form: GEL
Route: ORAL
Labeler: Hismile Pty Ltd
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-09
Substance: SODIUM FLUORIDE
Active strength: .243 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast
Listing expiration: 2026-12-31

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
2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	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
83013-331-06	Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast	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
83013-331	HISMILE GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST (SODIUM FLUORIDE) GEL [HISMILE PTY LTD]	2	Current NDC, 1 package rows	20250315_2b3e72ca-2bbb-adf1-e063-6394a90a2c7a.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 11 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRO-SYS	SENSITIVITY - MINT (OTC)	Benco Dental	4e46847e-8c1d-c988-e063-6394a90a8e50	2026-04-22	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	87327a36-a314-4daa-83b6-b4bd3e26bba2	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	8df324a7-9204-40f3-8ddb-1656286d7d4e	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	3bba340e-2a62-3b04-41b5-0ed9c13adb13	2026-04-22	Warnings	Exact identifier application number: M021
EverSmile Squirt	SODIUM FLUORIDE 0.05%	Everbrands, Inc.	bc0ef174-2909-469a-b629-0eab4412bdfc	2026-04-20	Warnings	Exact identifier application number: M021
Gum Detoxify	STANNOUS FLUORIDE	Walmart	41d6cc7a-0b87-e474-e063-6294a90ae995	2026-04-20	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf	2026-04-19	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	H E B	8d40f693-083c-4eb6-9da1-42675d757e0e	2026-04-16	Warnings, Adverse reactions	Exact identifier application number: M021
Eversmile OrthoFoam Anticavity	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	9c12e792-94c8-4e29-9a54-e7e70aadade6	2026-04-16	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	6753b426-6d49-4438-a52f-c28e60a0e9d8	2026-04-16	Warnings	Exact identifier application number: M021
Osstem G Gum Health Care Tooth	SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8b4fc0-4c98-5e52-e063-6394a90af710	2026-04-15	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Enamel Strength	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	4f6b8851-c778-8abd-e063-6294a90aef4f	2026-04-14		Exact identifier application number: M021
Crest 3D White Stain Eraser Luxe Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6beb3b-2521-bfb7-e063-6394a90ad9ea	2026-04-14		Exact identifier application number: M021
Kids Crest Strawberry Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6d11b2-5aa2-ab34-e063-6294a90ac0bc	2026-04-14	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Publix Super Markets, Inc.	cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Publix Super Markets, Inc.	f0e84078-499f-4a5a-bcd2-23f57805de86	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Pro-Health Advanced Multi-Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1cfc5b61-c8e5-943d-e063-6394a90a890b	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Multi-Protection plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6f6299-f95f-2f0e-e063-6294a90a1641	2026-04-14	Warnings	Exact identifier application number: M021
Crest 3D White Strength Whitening Enamel Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f7125aa-3aa2-ca64-e063-6394a90a4cf3	2026-04-14	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	2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	2
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	2
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	2
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	2
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83013-331-06	83013033106	60 g in 1 BOTTLE, PUMP (83013-331-06)	60 g	2025-01-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpaste	Hismile Pty Ltd \| Accupac LLC	2025-03-13	HUMAN OTC DRUG LABEL	2