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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Murchison Hume Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	b1a442e1-86cf-cba6-e053-2995a90a593a	2023-12-20	Warnings	Exact identifier application number: M021
United Airlines Polaris Kit with Colgate	SODIUM MONOFLUOROPHOSPHATE	Buzz Export Services Pty Ltd (Buzz Products)	de4564a4-1012-baad-e053-2a95a90a11b7	2023-12-20	Warnings	Exact identifier application number: M021
Orajel Complete Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	daebd16f-d278-446d-8b7a-33add5a74fdd	2023-12-19	Warnings	Exact identifier application number: M021
Orajel Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	Church & Dwight Co., Inc.	7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb	2023-12-19	Warnings	Exact identifier application number: M021
ORTHO GUARD	SODIUM FLUORIDE	Massco Dental A Division of Dunagin Pharmaceuticals	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd	2023-12-17	Warnings	Exact identifier application number: M021
Beyond Activated Coconut Charcoal and Sea Salt	SODIUM FLUORIDE	Beyond International Inc	d075fa15-7309-0c10-e053-2995a90a7c95	2023-11-28	Warnings	Exact identifier application number: M021
Pro-Den Rx	STANNOUS FLUORIDE	Den-mat Holdings, Llc	9036aa8a-59b1-41b0-b3cb-529d3303a1c0	2023-11-20	Warnings	Exact identifier application number: M021
Fluoridex	STANNOUS FLUORIDE RINSE	DEN-MAT HOLDINGS, LLC	5e81f073-c0ca-aa38-e053-2a91aa0ab37b	2023-11-20	Warnings	Exact identifier application number: M021
Hello Vitamin C Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	38a0276e-910c-527d-1736-65928b9d4ca4	2023-11-20	Warnings	Exact identifier application number: M021
POP Feeling Peachy	SODIUM FLUORIDE	LG H&H CO., LTD.	0abaf99b-9547-46ae-e063-6394a90a6c15	2023-11-17	Warnings	Exact identifier application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	e3356374-befa-41b0-ab0f-edfd5a062601	2023-11-16	Warnings	Exact identifier application number: M021
ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	421fc2f0-b118-4e7a-a399-ba4780028c54	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE	SODIUM FLUORIDE	Universal Distribution Center LLC	3411924d-1002-460c-83e8-c0c7fbff9ad1	2023-11-16	Warnings	Exact identifier application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	879dfaf0-27c8-41a3-8d01-a1c3eec9edfc	2023-11-15	Warnings	Exact identifier application number: M021
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	0989936c-237d-dc63-e063-6294a90a885f	2023-11-07	Warnings	Exact identifier application number: M021
Eurofresh Whitening	SODIUM FLUORIDE	Farmasi US LLC	b56b2b55-e3a4-785a-e053-2a95a90a7abf	2023-11-05	Warnings	Exact identifier application number: M021
Farmasi Whitening	SODIUM FLUORIDE	Farmasi US LLC	25b3608e-abed-41ca-9971-21981b8a4610	2023-11-05	Warnings	Exact identifier application number: M021
United Airlines Therabody UPP Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	fb6c355b-a67d-c4b4-e053-6394a90a0e66	2023-10-26	Warnings	Exact identifier application number: M021
United Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	7f348fe7-9918-4934-bed0-f0a77c09d046	2023-10-26	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