Charm Tex Fluoride

Product NDC: 51289-200
11-digit product format: 512890200
Labeler code: 51289
Product ID: 51289-200_0bd50eca-83a5-4c15-95e7-460e07cd8779
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE
Route: DENTAL
Labeler: Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-07-10
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 1 g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 17 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51289-200		I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-01	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-02	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-03	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-04	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-05	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-06	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-07	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-08	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-09	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-10	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-11	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-12	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-13	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-14	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-15	I	Inactivated by FDA	2026-10-05
excluded package	package	51289-200	51289-200-16	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 7 · 374 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	51289-200-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-200-15	`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	51289-200-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-200-15	`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	51289-200-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-200-15	`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	51289-200-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-200-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-200-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-200-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-200-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-200-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-200-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-200-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
51289-200-01	TOOTHPASTE DRUG FACTS
51289-200-02	TOOTHPASTE DRUG FACTS
51289-200-03	TOOTHPASTE DRUG FACTS
51289-200-04	TOOTHPASTE DRUG FACTS
51289-200-05	TOOTHPASTE DRUG FACTS
51289-200-06	TOOTHPASTE DRUG FACTS
51289-200-07	TOOTHPASTE DRUG FACTS
51289-200-08	TOOTHPASTE DRUG FACTS
51289-200-09	TOOTHPASTE DRUG FACTS
51289-200-10	TOOTHPASTE DRUG FACTS
51289-200-11	TOOTHPASTE DRUG FACTS
51289-200-12	TOOTHPASTE DRUG FACTS
51289-200-13	TOOTHPASTE DRUG FACTS
51289-200-14	TOOTHPASTE DRUG FACTS
51289-200-15	TOOTHPASTE DRUG FACTS
51289-200-16	TOOTHPASTE DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51289-200-01	Charm Tex Fluoride	17 g in 1 TUBE	PASTE	17	1
51289-200-02	Charm Tex Fluoride	24 g in 1 TUBE	PASTE	24	1
51289-200-03	Charm Tex Fluoride	35 g in 1 TUBE	PASTE	35	1
51289-200-04	Charm Tex Fluoride	43 g in 1 TUBE	PASTE	43	1
51289-200-05	Charm Tex Fluoride	50 g in 1 TUBE	PASTE	50	1
51289-200-06	Charm Tex Fluoride	70 g in 1 TUBE	PASTE	70	1
51289-200-07	Charm Tex Fluoride	78 g in 1 TUBE	PASTE	78	1
51289-200-08	Charm Tex Fluoride	90 g in 1 TUBE	PASTE	90	1
51289-200-09	Charm Tex Fluoride	100 g in 1 TUBE	PASTE	100	1
51289-200-10	Charm Tex Fluoride	120 g in 1 TUBE	PASTE	120	1
51289-200-11	Charm Tex Fluoride	130 g in 1 TUBE	PASTE	130	1
51289-200-12	Charm Tex Fluoride	150 g in 1 TUBE	PASTE	150	1
51289-200-13	Charm Tex Fluoride	180 g in 1 TUBE	PASTE	180	1
51289-200-14	Charm Tex Fluoride	3 g in 1 TUBE	PASTE	3	1
51289-200-15	Charm Tex Fluoride	5 g in 1 TUBE	PASTE	5	1
51289-200-16	Charm Tex Fluoride	10 g in 1 TUBE	PASTE	10	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
SILICA DIMETHYL SILYLATE	INACTIVE INGREDIENT	EU2PSP0G0W	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51289-200	CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	1	Legacy NDC, 16 package rows	20130710_c7acded8-16ea-4e4f-802e-7a75d3086d31.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	c7acded8-16ea-4e4f-802e-7a75d3086d31	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	c7acded8-16ea-4e4f-802e-7a75d3086d31	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	c7acded8-16ea-4e4f-802e-7a75d3086d31	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	c7acded8-16ea-4e4f-802e-7a75d3086d31	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	c7acded8-16ea-4e4f-802e-7a75d3086d31	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	c7acded8-16ea-4e4f-802e-7a75d3086d31	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51289-200-01	51289020001	17 g in 1 TUBE	17 g	Historical
51289-200-02	51289020002	24 g in 1 TUBE	24 g	Historical
51289-200-03	51289020003	35 g in 1 TUBE	35 g	Historical
51289-200-04	51289020004	43 g in 1 TUBE	43 g	Historical
51289-200-05	51289020005	50 g in 1 TUBE	50 g	Historical
51289-200-06	51289020006	70 g in 1 TUBE	70 g	Historical
51289-200-07	51289020007	78 g in 1 TUBE	78 g	Historical
51289-200-08	51289020008	90 g in 1 TUBE	90 g	Historical
51289-200-09	51289020009	100 g in 1 TUBE	100 g	Historical
51289-200-10	51289020010	120 g in 1 TUBE	120 g	Historical
51289-200-11	51289020011	130 g in 1 TUBE	130 g	Historical
51289-200-12	51289020012	150 g in 1 TUBE	150 g	Historical
51289-200-13	51289020013	180 g in 1 TUBE	180 g	Historical
51289-200-14	51289020014	3 g in 1 TUBE	3 g	Historical
51289-200-15	51289020015	5 g in 1 TUBE	5 g	Historical
51289-200-16	51289020016	10 g in 1 TUBE	10 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOOTHPASTE DRUG FACTS	Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.	2013-07-10	HUMAN OTC DRUG LABEL	1