Charm Tex

Product NDC: 40057-1001
11-digit product format: 400571001
Labeler code: 40057
Product ID: 40057-1001_7375cd98-281b-4ece-bdc5-14ab02eaf788
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Charm Tex, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-06-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	40057-1001		I	Inactivated by FDA	2026-10-05
excluded package	package	40057-1001	40057-1001-1	I	Inactivated by FDA	2026-10-05
excluded package	package	40057-1001	40057-1001-2	I	Inactivated by FDA	2026-10-05
excluded package	package	40057-1001	40057-1001-3	I	Inactivated by FDA	2026-10-05
excluded package	package	40057-1001	40057-1001-4	I	Inactivated by FDA	2026-10-05
excluded package	package	40057-1001	40057-1001-5	I	Inactivated by FDA	2026-10-05
excluded package	package	40057-1001	40057-1001-6	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 3 · 154 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	40057-1001-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40057-1001-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40057-1001-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40057-1001-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40057-1001-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40057-1001-4	`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	40057-1001-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40057-1001-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40057-1001-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40057-1001-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40057-1001-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40057-1001-4	`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	40057-1001-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40057-1001-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40057-1001-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40057-1001-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40057-1001-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40057-1001-4	`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	40057-1001-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40057-1001-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40057-1001-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40057-1001-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40057-1001-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40057-1001-4	`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	40057-1001-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40057-1001-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40057-1001-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40057-1001-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40057-1001-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40057-1001-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40057-1001-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40057-1001-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40057-1001-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40057-1001-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40057-1001-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40057-1001-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40057-1001-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40057-1001-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40057-1001-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40057-1001-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40057-1001-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40057-1001-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40057-1001-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40057-1001-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40057-1001-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40057-1001-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40057-1001-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40057-1001-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40057-1001-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40057-1001-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40057-1001-5	`0efc9e666f02…`	`f202fb6c5f17…`

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
40057-1001-1	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-2	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-3	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-4	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-5	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-6	Charm-Tex FLUORIDE GEL TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
40057-1001-1	Charm Tex	141 g in 1 TUBE	PASTE, DENTIFRICE	141	1
40057-1001-2	Charm Tex	85 g in 1 TUBE	PASTE, DENTIFRICE	85	1
40057-1001-3	Charm Tex	42.5 g in 1 TUBE	PASTE, DENTIFRICE	42.5	1
40057-1001-4	Charm Tex	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
40057-1001-5	Charm Tex	17 g in 1 TUBE	PASTE, DENTIFRICE	17	1
40057-1001-6	Charm Tex	4.24 g in 1 POUCH	PASTE, DENTIFRICE	4.24	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Methylparaben Sodium	INACTIVE INGREDIENT	CR6K9C2NHK	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Propylparaben Sodium	INACTIVE INGREDIENT	625NNB0G9N	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40057-1001	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1	Legacy NDC, 6 package rows	20120106_3579fd94-ee49-4608-94dc-401b66a78ec2.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
245598	sodium fluoride 0.22 % Toothpaste	PSN	3579fd94-ee49-4608-94dc-401b66a78ec2	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	3579fd94-ee49-4608-94dc-401b66a78ec2	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	3579fd94-ee49-4608-94dc-401b66a78ec2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
40057-1001-1	40057100101	141 g in 1 TUBE	141 g	Historical
40057-1001-2	40057100102	85 g in 1 TUBE	85 g	Historical
40057-1001-3	40057100103	42.5 g in 1 TUBE	42.5 g	Historical
40057-1001-4	40057100104	24 g in 1 TUBE	24 g	Historical
40057-1001-5	40057100105	17 g in 1 TUBE	17 g	Historical
40057-1001-6	40057100106	4.24 g in 1 POUCH	4.24 g	Historical