Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

Product NDC: 85162-003
11-digit product format: 851620003
Labeler code: 85162
Product ID: 85162-003_2bce1352-ed26-a13d-e063-6394a90a2d08
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Yangzhou ONE & ONLY Personal Care Products Co., LTD
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-16
Substance: SODIUM FLUORIDE
Active strength: .1 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: Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.1 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
bb93fb1a-885a-4d2a-a1c2-3b37bc305d57	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85162-003-01	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-003-01	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
85162-003-02	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	24 in 1 BOX	PASTE, DENTIFRICE	24	1
85162-003-02	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	5 in 1 CARTON	PASTE, DENTIFRICE	5	1
85162-003-03	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	50 g in 1 TUBE	PASTE, DENTIFRICE	50	1
85162-003-03	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-003-04	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	100 g in 1 TUBE	PASTE, DENTIFRICE	100	1
85162-003-04	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	72 in 1 BOX	PASTE, DENTIFRICE	72	1
85162-003-05	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	100 g in 1 TUBE	PASTE, DENTIFRICE	100	1
85162-003-05	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-003-06	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	28 g in 1 TUBE	PASTE, DENTIFRICE	28	1
85162-003-06	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	480 in 1 BOX	PASTE, DENTIFRICE	480	1
85162-003-07	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	72 in 1 BOX	PASTE, DENTIFRICE	72	1
85162-003-07	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	120 g in 1 TUBE	PASTE, DENTIFRICE	120	1
85162-003-08	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	120 g in 1 TUBE	PASTE, DENTIFRICE	120	1
85162-003-08	Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth	144 in 1 BOX	PASTE, DENTIFRICE	144	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85162-003	PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]	1	Current NDC, 16 package rows	20250117_bb93fb1a-885a-4d2a-a1c2-3b37bc305d57.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
United Airlines Therabody Polaris Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	ab667740-55ab-470e-9514-163961502ceb	2023-10-26	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	0ae98f28-7e78-4379-93b0-4f2657415c4d	2023-10-25	Warnings	Exact identifier application number: M021
Tanners Tasty Vanilla Bling	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	521fe01e-7f2e-4d79-9126-e4880cdf4e71	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Ooh La La Orange	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	6027b961-314e-4f71-8b2f-646ce80214d8	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Cha Cha Chocolate	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	8609dbf3-7620-4a13-b40b-6bd705a78fb0	2023-10-24	Warnings	Exact identifier application number: M021
Glister Multi-Action	SODIUM FLUORIDE	Access Business Group LLC	e3f2c049-a0f5-4649-a4aa-11bdb252f951	2023-10-23	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	MING FAI ENTERPRISE (CAMBODIA) CO., LTD	082a581a-c7e5-e614-e063-6394a90a87da	2023-10-20	Warnings	Exact identifier application number: M021
Plak Smacker Anti Cavity Fluoride	SODIUM FLUORIDE	YOUNG PS ACQUISITION, LLC	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2023-10-16	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	152d84ee-d981-4032-bfb1-a559afe71d40	2023-10-11	Warnings	Exact identifier application number: M021
Sodium Fluoride	SODIUM FLUORIDE	Safco Dental Supply LLC	788080b3-fff8-4049-af98-f571824994c2	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	5c312b36-07f4-406e-b3d3-c6d1e964635d	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	042636cf-8b61-4022-b0a1-af09c06b145b	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	f4c3569b-7b6a-4566-9e87-492f291c5165	2023-10-11	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	Procurall Solutions	042817f9-675f-056a-e063-6394a90a2d97	2023-08-30	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Mission Hills S.A de C.V	d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	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	bb93fb1a-885a-4d2a-a1c2-3b37bc305d57	1
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	bb93fb1a-885a-4d2a-a1c2-3b37bc305d57	1
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	bb93fb1a-885a-4d2a-a1c2-3b37bc305d57	1
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	bb93fb1a-885a-4d2a-a1c2-3b37bc305d57	1
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	bb93fb1a-885a-4d2a-a1c2-3b37bc305d57	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85162-003-01	85162000301	144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-003-02	85162000302	5 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE	5 box	2025-01-16	No	No	Current
85162-003-03	85162000303	144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-003-04	85162000304	72 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE	72 tube	2025-01-16	No	No	Current
85162-003-05	85162000305	144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-003-06	85162000306	480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE	480 tube	2025-01-16	No	No	Current
85162-003-07	85162000307	72 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE	72 tube	2025-01-16	No	No	Current
85162-003-08	85162000308	144 TUBE in 1 BOX (85162-003-08) / 120 g in 1 TUBE	144 tube	2025-01-16	No	No	Current