AmerFresh

Product NDC: 51460-1111
11-digit product format: 514601111
Labeler code: 51460
Product ID: 51460-1111_f4796a85-7502-4122-92d5-4c8af32d3273
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL, DENTIFRICE
Route: ORAL
Labeler: Amercare Products, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-11-14
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/85g
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51460-1111		I	Inactivated by FDA	2026-10-12
excluded package	package	51460-1111	51460-1111-1	I	Inactivated by FDA	2026-10-12
excluded package	package	51460-1111	51460-1111-2	I	Inactivated by FDA	2026-10-12
excluded package	package	51460-1111	51460-1111-3	I	Inactivated by FDA	2026-10-12
excluded package	package	51460-1111	51460-1111-4	I	Inactivated by FDA	2026-10-12
excluded package	package	51460-1111	51460-1111-5	I	Inactivated by FDA	2026-10-12
excluded package	package	51460-1111	51460-1111-6	I	Inactivated by FDA	2026-10-12
excluded package	package	51460-1111	51460-1111-7	I	Inactivated by FDA	2026-10-12

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 · 176 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	51460-1111-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1111-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1111-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1111-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1111-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1111-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1111-4	`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	51460-1111-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1111-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1111-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1111-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1111-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1111-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1111-4	`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	51460-1111-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1111-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1111-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1111-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1111-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1111-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1111-4	`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	51460-1111-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1111-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1111-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1111-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1111-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1111-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1111-4	`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	51460-1111-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1111-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1111-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1111-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1111-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1111-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1111-4	`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	51460-1111-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1111-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1111-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1111-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1111-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1111-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1111-4	`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	51460-1111-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51460-1111-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51460-1111-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51460-1111-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51460-1111-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51460-1111-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51460-1111-4	`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	51460-1111-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51460-1111-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51460-1111-3	`ed331223b511…`	`672a5bd82f5f…`

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
51460-1111-1	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-2	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-3	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-4	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-5	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-6	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-7	AmerFresh ® Fluoride Gel Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51460-1111-1	AmerFresh	85 g in 1 TUBE	GEL, DENTIFRICE	85	1
51460-1111-2	AmerFresh	7.1 g in 1 PACKET	GEL, DENTIFRICE	7.1	1
51460-1111-3	AmerFresh	17 g in 1 TUBE	GEL, DENTIFRICE	17	1
51460-1111-4	AmerFresh	24 g in 1 TUBE	GEL, DENTIFRICE	24	1
51460-1111-5	AmerFresh	43 g in 1 TUBE	GEL, DENTIFRICE	43	1
51460-1111-6	AmerFresh	130 g in 1 TUBE	GEL, DENTIFRICE	130	1
51460-1111-7	AmerFresh	181 g in 1 TUBE	GEL, DENTIFRICE	181	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Methylparaben Sodium	INACTIVE INGREDIENT	CR6K9C2NHK	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Propylparaben Sodium	INACTIVE INGREDIENT	625NNB0G9N	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51460-1111	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1	Legacy NDC, 7 package rows	20121127_7d12eab2-ad71-4743-9c47-2f3b3bc2aa81.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	7d12eab2-ad71-4743-9c47-2f3b3bc2aa81	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	7d12eab2-ad71-4743-9c47-2f3b3bc2aa81	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	7d12eab2-ad71-4743-9c47-2f3b3bc2aa81	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51460-1111-1	51460111101	85 g in 1 TUBE	85 g	Historical
51460-1111-2	51460111102	7.1 g in 1 PACKET	7.1 g	Historical
51460-1111-3	51460111103	17 g in 1 TUBE	17 g	Historical
51460-1111-4	51460111104	24 g in 1 TUBE	24 g	Historical
51460-1111-5	51460111105	43 g in 1 TUBE	43 g	Historical
51460-1111-6	51460111106	130 g in 1 TUBE	130 g	Historical
51460-1111-7	51460111107	181 g in 1 TUBE	181 g	Historical