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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Lidl US, LLC	c47475aa-3125-410f-aa31-0add6e4ce125	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Brilliance Pro Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f4c02924-95ee-09d2-e053-2995a90a8121	2026-02-03		Exact identifier application number: M021
Crest 3D White Stain Eraser Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5d97011-7be3-3b1c-e053-2a95a90ade86	2026-02-03		Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc.	c28c3475-efbb-4099-83ab-ab91bac9dfc3	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Demoulas Super Markets, Inc	65abfb4d-3a1e-42df-b343-f270ce60a3bf	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	102e4d9c-0fae-d48a-e063-6294a90aac94	2026-02-03	Warnings	Exact identifier application number: M021
Crest Plus Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08767b0f-ed6e-8d32-e063-6294a90a10cd	2026-02-03	Warnings	Exact identifier application number: M021
Crest Braces Care Anticavity Fluoride Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d8398cfd-9af6-690d-e053-2995a90a9b7c	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	d859d02d-a036-4d90-bed4-9a5c31e9e1ef	2026-02-03	Warnings	Exact identifier application number: M021
Glowing White	SODIUM FLUORIDE	Demoulas Super Markets, Inc	32faf47d-b64f-4454-9f14-51503504c6b5	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Sodium fluoride	SODIUM FLUORIDE	Demoulas Super Markets, Inc	2f5d3c75-1a11-47e1-b297-e2302177efe7	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc	096e6a1d-316b-432a-bf27-70e8a13337cc	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	49d1932f-a85c-7b8f-e063-6394a90a6aca	2026-02-02	Warnings	Exact identifier application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	49d4f96f-e61f-e6e6-e063-6294a90ab0a0	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Toy Story Wild West Watermelon	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d69901-0b07-b07d-e063-6394a90a3c34	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Frozen Blizzard Berry	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d6c1c9-cd21-cac6-e063-6294a90a81d6	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Disney Princesses Grand Grape	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d6f926-da4e-26df-e063-6294a90a1c0c	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker Punch	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d70b88-d57c-37cd-e063-6294a90a4a59	2026-02-02	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Rite Aid Corporation	54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe	2026-02-02	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
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