Plak Smacker Anti Cavity Fluoride

Product NDC: 72326-8002
11-digit product format: 723268002
Labeler code: 72326
Product ID: 72326-8002_07d5baa5-6b43-e0fa-e063-6394a90a9565
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE
Route: DENTAL
Labeler: YOUNG PS ACQUISITION, LLC
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-05-27
Substance: SODIUM FLUORIDE
Active strength: 1.4 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	72326-8002-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	72326-8002-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	72326-8002-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	72326-8002-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	72326-8002-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	72326-8002-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	72326-8002-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	72326-8002-3	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	72326-8002-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	72326-8002-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	72326-8002-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	72326-8002-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	72326-8002-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	72326-8002-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	72326-8002-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	72326-8002-1	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	72326-8002-3	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	72326-8002-2	`9bebd1f3094a…`	`5416666fcb17…`

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 Anti Cavity Fluoride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1.4 mg/g

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
c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
72326-8002-1	2023-11-21	Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-2	2023-11-21	Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-3	2023-11-21	Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-1	2020-01-31	Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-2	2020-01-31	Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-3	2020-01-31	Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72326-8002-1	Plak Smacker Anti Cavity Fluoride	24 g in 1 TUBE	PASTE	24	2
72326-8002-2	Plak Smacker Anti Cavity Fluoride	120 g in 1 TUBE	PASTE	120	2
72326-8002-3	Plak Smacker Anti Cavity Fluoride	24 g in 1 TUBE	PASTE	24	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72326-8002	PLAK SMACKER ANTI CAVITY FLUORIDE (SODIUM FLUORIDE) PASTE [YOUNG PS ACQUISITION, LLC]	2	Current NDC, Legacy NDC, 3 package rows	20231122_c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe.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 21 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1de591d9-9cab-e63d-e063-6394a90ac8eb	2026-01-15	Warnings	Exact identifier application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	HISMILE PTY LTD	20e1603e-bcd1-6a5e-e063-6294a90ad1db	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	HISMILE PTY LTD	1e725b7e-accc-f51c-e063-6394a90a455c	2026-01-15	Warnings	Exact identifier application number: M021
Enamelon Preventive Treatment	STANNOUS FLUORIDE	Premier Dental Products Company	04c3f178-7905-404d-9ac2-67c453287ddf	2026-01-13	Warnings	Exact identifier application number: M021
Enamelon	STANNOUS FLUORIDE	Premier Dental Products Company	1626375a-f78b-4192-b7f3-ca932acab7fb	2026-01-13	Warnings	Exact identifier application number: M021
ARU CAVITY PROTECTION	SODIUM FLUORIDE	Ashtel Studios, Inc.	97bd2934-4bff-4fdb-9199-fcdc0f77fada	2026-01-13	Warnings	Exact identifier application number: M021
ACT Anticavity Fluoride Cinnamon	SODIUM FLUORIDE	Chattem, Inc.	f2952ca5-c1c3-42fc-82a4-08662286be44	2026-01-12	Warnings	Exact identifier application number: M021
ACT Anticavity Fluoride Kids Wild Watermelon	SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)	Chattem, Inc.	bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8	2026-01-12	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Pineapple Punch	SODIUM FLUORIDE	Chattem, Inc.	2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b	2026-01-12	Warnings	Exact identifier application number: M021
Botao Kids Strawberry Flavored with Fluoride	BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE	Peer Pharm Ltd.	48b8d884-5e15-4145-8521-ae9ee482e392	2026-01-12	Warnings	Exact identifier application number: M021
ACT Total Care Anticavity Fluoride Fresh Mint	SODIUM FLUORIDE	Chattem, Inc.	4ee6a478-afcf-4540-b427-ba08c942ccb3	2026-01-12	Warnings	Exact identifier application number: M021
ACT Anticavity Fluoride Mint	SODIUM FLUORIDE	Chattem, Inc.	e81c83a2-363a-442f-8731-2598a4f4c21e	2026-01-12	Warnings	Exact identifier application number: M021
ACT Total Care Anticavity Fluoride Icy Clean Mint	SODIUM FLUORIDE	Chattem, Inc.	258b78b4-55e7-410c-90f8-a3e456c02579	2026-01-12	Warnings	Exact identifier application number: M021
ACT Total Care Dry Mouth Anticavity Mouth	SODIUM FLUORIDE	Chattem, Inc.	06684b82-aaa0-4ca6-8d56-4f9866269000	2026-01-12	Warnings	Exact identifier application number: M021
ACT Anticavity Fluoride Kids Groovy Grape	SODIUM FLUORIDE	Chattem, Inc.	cd167c0b-2086-4204-b0ac-90df404bd4bb	2026-01-12	Warnings	Exact identifier application number: M021
ACT Total Care Anticavity Fluoride Icy Clean Mint	SODIUM FLUORIDE	Chattem, Inc.	beded786-bb55-4ba3-82fe-9e9d1b5e2979	2026-01-12	Warnings	Exact identifier application number: M021
ACT Kids Pure Protect Anticavity- Simply Strawberry	SODIUM FLUORIDE	Chattem, Inc.	2fc80727-57c7-4a33-80e0-ab9f9487390d	2026-01-12	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Groovy Grape	SODIUM FLUORIDE	Chattem, Inc.	310a3c11-1c66-4dac-99f4-5fdc15d0f77c	2026-01-12	Warnings	Exact identifier application number: M021
ACT Anticavity Fluoride Kids Bubblegum	SODIUM FLUORIDE	Chattem, Inc.	fbbccd58-a816-4a93-a658-f28246c11e80	2026-01-12	Warnings	Exact identifier application number: M021
ACT Whitening Anticavity Gentle Mint	SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)	Chattem, Inc.	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	2026-01-12	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	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72326-8002-1	72326800201	24 g in 1 TUBE (72326-8002-1)	24 g	2023-07-12	No	No	Current
72326-8002-2	72326800202	120 g in 1 TUBE (72326-8002-2)	120 g	2023-07-12	No	No	Current
72326-8002-3	72326800203	24 g in 1 TUBE (72326-8002-3)	24 g	2023-07-12	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE	YOUNG PS ACQUISITION, LLC	2023-10-16	HUMAN OTC DRUG LABEL	2