Watermelon Flavor Sodium Fluoride Anticavity Toothpast

Product NDC: 83013-337
11-digit product format: 830130337
Labeler code: 83013
Product ID: 83013-337_426e40cb-e30e-0db1-e063-6294a90a762b
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL
Route: TOPICAL
Labeler: HISMILE PTY LTD
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-10-31
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: Watermelon 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
891775	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
426e40cb-e30d-0db1-e063-6294a90a762b	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
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
83013-337-10	Watermelon Flavor Sodium Fluoride Anticavity Toothpast	100 g in 1 TUBE	GEL	100		1

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 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Frida Fluoride Sweet Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b5a39-5d79-72cd-e063-6394a90a475c	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Bubble Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b9af3-e4b3-b5e0-e063-6394a90a1068	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry Toothbrush Set	SODIUM FLUORIDE	Fridababy, LLC	4f8ba14f-60ea-c2a8-e063-6394a90a7702	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry	SODIUM FLUORIDE	Fridababy, LLC	4f814a62-8f91-8ea6-e063-6294a90a69eb	2026-05-06	Warnings	Exact identifier application number: M021
Gum Health Detoxify	STANNOUS FLUORIDE	Meijer, Inc	41d70733-a223-40fb-e063-6294a90a1397	2026-05-06	Warnings	Exact identifier application number: M021
Colgate Kids Unicorn Alcohol Free	SODIUM FLUORIDE	Colgate-Palmolive Company	133acaff-7205-80d7-e91d-3eb37087cae4	2026-05-05	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	fdefffbd-9c05-fa30-e053-6394a90a34bc	2026-05-05	Warnings	Exact identifier application number: M021
Frida Fluoride Watermelon	SODIUM FLUORIDE	Fridababy, LLC	4f8b49dc-e9e4-c341-e063-6294a90adb5a	2026-05-05	Warnings	Exact identifier application number: M021
White Glo Extreme White Whitening	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	4a2e0a8d-420e-4c07-aa43-386d05dab472	2026-04-30	Warnings	Exact identifier application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TP	STANNOUS FLUORIDE	Walmart Inc.	1e6561fb-4e3b-40ba-e063-6294a90a2690	2026-04-29	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	852889b4-59ba-4592-b4fc-c0127a1ad075	2026-04-28	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Scope	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	0206710a-707f-4aa9-96b9-86240c1275dc	2026-04-28	Warnings	Exact identifier application number: M021
Alcohol Free Refreshing Mint	SODIUM FLUORIDE	H E B	cedf7c08-7412-4733-9b67-225b331cec8c	2026-04-27	Warnings, Adverse reactions	Exact identifier application number: M021
anzoon ANTIBACTERIAL MOUTH WASH	CETYLPYRIDINIUM CHLORIDE	Shandong AZC Biotechnology Co.,Ltd.	507c6896-2806-790c-e063-6394a90ac5ce	2026-04-27	Warnings	Exact identifier application number: M021
DELTA COMFORT PLUS AMENITY	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	26434794-ae02-0f58-e063-6294a90ad85e	2026-04-24	Warnings	Exact identifier application number: M021
A and H Plus Therabreath Breath Freshners	SODIUM FLUORIDE	Church & Dwight Co., Inc.	18d6073e-b1ee-47d2-9758-2cf04f3cf3ca	2026-04-23	Warnings	Exact identifier application number: M021
Fluoride	SODIUM FLUORIDE	McKesson	5025e58e-e59c-07b6-e063-6394a90ac1e8	2026-04-23	Warnings	Exact identifier application number: M021
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

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
891775	sodium fluoride 0.243 % Toothpaste	PSN	426e40cb-e30d-0db1-e063-6294a90a762b	1
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	426e40cb-e30d-0db1-e063-6294a90a762b	1
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	426e40cb-e30d-0db1-e063-6294a90a762b	1
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	426e40cb-e30d-0db1-e063-6294a90a762b	1
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	426e40cb-e30d-0db1-e063-6294a90a762b	1
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	426e40cb-e30d-0db1-e063-6294a90a762b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83013-337-10	83013033710	100 g in 1 TUBE (83013-337-10)	100 g	2025-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Watermelon Flavor Sodium Fluoride Anticavity Toothpaste	HISMILE PTY LTD \| Nutrix International, LLC.	2025-10-31	HUMAN OTC DRUG LABEL	1