PLAK SMACKER Anti-cavity Fluoride Gel

Product NDC: 71167-005
11-digit product format: 711670005
Labeler code: 71167
Product ID: 71167-005_675d324a-a218-fae2-e053-2a91aa0a6b80
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE
Route: DENTAL
Labeler: HUAIAN ZONGHENG BIO-TECH CO., LTD
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-02-02
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 14 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71167-005		I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-01	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-02	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-03	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-04	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-05	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-06	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-07	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-08	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-09	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-10	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-11	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-12	I	Inactivated by FDA	2026-10-05
excluded package	package	71167-005	71167-005-13	I	Inactivated by FDA	2026-10-05

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 5 · 294 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71167-005-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71167-005-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71167-005-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71167-005-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71167-005-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71167-005-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71167-005-13	`cfe11265f3b6…`	`090c488252e2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
71167-005-01	71167-005 PLAK SMACKER 0.24
71167-005-02	71167-005 PLAK SMACKER 0.24
71167-005-03	71167-005 PLAK SMACKER 0.24
71167-005-04	71167-005 PLAK SMACKER 0.24
71167-005-05	71167-005 PLAK SMACKER 0.24
71167-005-06	71167-005 PLAK SMACKER 0.24
71167-005-07	71167-005 PLAK SMACKER 0.24
71167-005-08	71167-005 PLAK SMACKER 0.24
71167-005-09	71167-005 PLAK SMACKER 0.24
71167-005-10	71167-005 PLAK SMACKER 0.24
71167-005-11	71167-005 PLAK SMACKER 0.24
71167-005-12	71167-005 PLAK SMACKER 0.24
71167-005-13	71167-005 PLAK SMACKER 0.24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71167-005-01	PLAK SMACKER Anti-cavity Fluoride Gel	144 in 1 CARTON	PASTE	144	2
71167-005-01	PLAK SMACKER Anti-cavity Fluoride Gel	24 g in 1 TUBE	PASTE	24	2
71167-005-02	PLAK SMACKER Anti-cavity Fluoride Gel	120 in 1 CARTON	PASTE	120	2
71167-005-02	PLAK SMACKER Anti-cavity Fluoride Gel	24 in 1 BOX	PASTE	24	2
71167-005-03	PLAK SMACKER Anti-cavity Fluoride Gel	24 in 1 BOX	PASTE	24	2
71167-005-03	PLAK SMACKER Anti-cavity Fluoride Gel	120 in 1 CARTON	PASTE	120	2
71167-005-04	PLAK SMACKER Anti-cavity Fluoride Gel	144 in 1 CARTON	PASTE	144	2
71167-005-04	PLAK SMACKER Anti-cavity Fluoride Gel	50 g in 1 TUBE	PASTE	50	2
71167-005-05	PLAK SMACKER Anti-cavity Fluoride Gel	100 g in 1 TUBE	PASTE	100	2
71167-005-05	PLAK SMACKER Anti-cavity Fluoride Gel	72 in 1 CARTON	PASTE	72	2
71167-005-06	PLAK SMACKER Anti-cavity Fluoride Gel	144 in 1 BOX	PASTE	144	2
71167-005-06	PLAK SMACKER Anti-cavity Fluoride Gel	100 g in 1 TUBE	PASTE	100	2
71167-005-07	PLAK SMACKER Anti-cavity Fluoride Gel	28 g in 1 TUBE	PASTE	28	2
71167-005-07	PLAK SMACKER Anti-cavity Fluoride Gel	480 in 1 BOX	PASTE	480	2
71167-005-08	PLAK SMACKER Anti-cavity Fluoride Gel	120 g in 1 TUBE	PASTE	120	2
71167-005-08	PLAK SMACKER Anti-cavity Fluoride Gel	72 in 1 BOX	PASTE	72	2
71167-005-09	PLAK SMACKER Anti-cavity Fluoride Gel	120 g in 1 TUBE	PASTE	120	2
71167-005-09	PLAK SMACKER Anti-cavity Fluoride Gel	144 in 1 BOX	PASTE	144	2
71167-005-10	PLAK SMACKER Anti-cavity Fluoride Gel	50 g in 1 TUBE	PASTE	50	2
71167-005-10	PLAK SMACKER Anti-cavity Fluoride Gel	288 in 1 BOX	PASTE	288	2
71167-005-11	PLAK SMACKER Anti-cavity Fluoride Gel	480 in 1 CARTON	PASTE	480	2
71167-005-11	PLAK SMACKER Anti-cavity Fluoride Gel	24 in 1 BOX	PASTE	24	2
71167-005-12	PLAK SMACKER Anti-cavity Fluoride Gel	576 in 1 CARTON	PASTE	576	2
71167-005-12	PLAK SMACKER Anti-cavity Fluoride Gel	144 in 1 BOX	PASTE	144	2
71167-005-13	PLAK SMACKER Anti-cavity Fluoride Gel	72 in 1 CARTON	PASTE	72	2
71167-005-13	PLAK SMACKER Anti-cavity Fluoride Gel	12 in 1 BOX	PASTE	12	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71167-005	PLAK SMACKER ANTI-CAVITY FLUORIDE GEL (SODIUM FLUORIDE) PASTE [HUAIAN ZONGHENG BIO-TECH CO., LTD]	2	Legacy NDC, 26 package rows	20180314_6657b534-f79a-0407-e053-2a91aa0a0f45.zip

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	6657b534-f79a-0407-e053-2a91aa0a0f45	2
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	6657b534-f79a-0407-e053-2a91aa0a0f45	2
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	6657b534-f79a-0407-e053-2a91aa0a0f45	2
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	6657b534-f79a-0407-e053-2a91aa0a0f45	2
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	6657b534-f79a-0407-e053-2a91aa0a0f45	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
71167-005-01	71167000501	144 in 1 CARTON		Historical
71167-005-02	71167000502	120 in 1 CARTON		Historical
71167-005-03	71167000503	24 in 1 BOX		Historical
71167-005-04	71167000504	144 in 1 CARTON		Historical
71167-005-05	71167000505	100 g in 1 TUBE	100 g	Historical
71167-005-06	71167000506	144 in 1 BOX		Historical
71167-005-07	71167000507	28 g in 1 TUBE	28 g	Historical
71167-005-08	71167000508	120 g in 1 TUBE	120 g	Historical
71167-005-09	71167000509	120 g in 1 TUBE	120 g	Historical
71167-005-10	71167000510	50 g in 1 TUBE	50 g	Historical
71167-005-11	71167000511	480 in 1 CARTON		Historical
71167-005-12	71167000512	576 in 1 CARTON		Historical
71167-005-13	71167000513	72 in 1 CARTON		Historical