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 9 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Optimax Anticavity Fluoride Raspberry	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	57e1d1cb-da58-4cd2-b960-4056e0b0d214	2026-06-05	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteeth	POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fc83e-a8cf-15c1-e063-6294a90a7b74	2026-06-02	Warnings	Exact identifier application number: M021
Walgreens Restore and Defend	STANNOUS FLUORIDE	Walgreens	e808ea4b-9081-085b-e053-2a95a90a4f9b	2026-06-02	Warnings	Exact identifier application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinse	SODIUM FLUORIDE	Colgate-Palmolive Company	a1014431-7d23-aaff-6dc7-ab58683d0338	2026-06-02	Warnings	Exact identifier application number: M021
Therabreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	feab3d45-ff95-4b32-8258-7d932a7380c9	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Toy Story 5 Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b80947d-f389-2f80-e063-6294a90abd55	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	54113245-0c1e-739e-e063-6294a90aea42	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	545258fd-8179-fffc-e063-6394a90a467f	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Paw Patrol	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d87bea-3e99-5d04-e053-2a95a90aaf54	2026-06-01	Warnings	Exact identifier application number: M021
Orajel SuperMario	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	27d2f6cb-8661-da9c-e063-6394a90a5bde	2026-06-01	Warnings	Exact identifier application number: M021
Orajel KidsToothpaste	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d62125-c2c5-5926-e053-2995a90aaa29	2026-06-01	Warnings	Exact identifier application number: M021
AIM CAVITY PROTECTION Multi Benefit	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0f8a33-0b01-40e2-e054-00144ff88e88	2026-06-01	Warnings	Exact identifier application number: M021
Crest plus Tartar Protection Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560980ea-749f-593d-e063-6394a90a1b9e	2026-06-01	Warnings	Exact identifier application number: M021
Colgate Revitalizing White	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	c67223ae-b068-41c5-a15b-7ae9840b93ef	2026-05-27	Warnings	Exact identifier application number: M021
Colgate Kids Harry Potter	SODIUM FLUORIDE	Colgate-Palmolive Company	61c06da4-9f02-4fbc-b80f-1c443e298496	2026-05-26	Warnings	Exact identifier application number: M021
sodium fluoride rinse	SODIUM FLUORIDE RINSE	Rockland Cosmetics, Inc.	52430b12-4d5f-d1e1-e063-6394a90abd64	2026-05-20	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	d0a52519-3339-40ea-93e5-78f76d348a4d	2026-05-14	Warnings, Adverse reactions	Exact identifier application number: M021
Burts Bees Extra White	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c92524fd-8b93-592d-e053-2a95a90a88c6	2026-05-13	Warnings	Exact identifier application number: M021
MIPaste Plus Strawberry	SODIUM FLUORIDE	GC America Inc.	1b68bd67-65d3-4c64-e054-00144ff8d46c	2026-05-12	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