AmerFresh

Product NDC: 51460-1112
11-digit product format: 514601112
Labeler code: 51460
Product ID: 51460-1112_26239955-403c-4dcd-9e8e-0b36d44a7e01
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate
Dosage form: PASTE, 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 MONOFLUOROPHOSPHATE
Active strength: 1 mg/g
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51460-1112		I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-0	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-1	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-2	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-3	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-4	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-5	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-6	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-7	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-8	I	Inactivated by FDA	2026-10-15
excluded package	package	51460-1112	51460-1112-9	I	Inactivated by FDA	2026-10-15

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 · 242 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	51460-1112-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51460-1112-0	`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	51460-1112-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51460-1112-0	`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	51460-1112-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51460-1112-0	`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	51460-1112-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51460-1112-0	`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	51460-1112-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51460-1112-0	`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	51460-1112-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1112-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1112-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51460-1112-8	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51460-1112-0	AmerFresh ® Fluoride Toothpaste
51460-1112-1	AmerFresh ® Fluoride Toothpaste
51460-1112-2	AmerFresh ® Fluoride Toothpaste
51460-1112-3	AmerFresh ® Fluoride Toothpaste
51460-1112-4	AmerFresh ® Fluoride Toothpaste
51460-1112-5	AmerFresh ® Fluoride Toothpaste
51460-1112-6	AmerFresh ® Fluoride Toothpaste
51460-1112-7	AmerFresh ® Fluoride Toothpaste
51460-1112-8	AmerFresh ® Fluoride Toothpaste
51460-1112-9	AmerFresh ® Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51460-1112-0	AmerFresh	142 g in 1 TUBE	PASTE, DENTIFRICE	142	3
51460-1112-1	AmerFresh	85 g in 1 TUBE	PASTE, DENTIFRICE	85	3
51460-1112-2	AmerFresh	7.1 g in 1 PACKET	PASTE, DENTIFRICE	7.1	3
51460-1112-3	AmerFresh	85 g in 1 TUBE	PASTE, DENTIFRICE	85	3
51460-1112-3	AmerFresh	1 in 1 BOX	PASTE, DENTIFRICE	1	3
51460-1112-4	AmerFresh	17 g in 1 TUBE	PASTE, DENTIFRICE	17	3
51460-1112-5	AmerFresh	24 g in 1 TUBE	PASTE, DENTIFRICE	24	3
51460-1112-6	AmerFresh	43 g in 1 TUBE	PASTE, DENTIFRICE	43	3
51460-1112-7	AmerFresh	1 in 1 BOX	PASTE, DENTIFRICE	1	3
51460-1112-7	AmerFresh	43 g in 1 TUBE	PASTE, DENTIFRICE	43	3
51460-1112-8	AmerFresh	130 g in 1 TUBE	PASTE, DENTIFRICE	130	3
51460-1112-9	AmerFresh	181 g in 1 TUBE	PASTE, DENTIFRICE	181	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Calcium Carbonate	INACTIVE INGREDIENT	H0G9379FGK	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Methylparaben Sodium	INACTIVE INGREDIENT	CR6K9C2NHK	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Propylparaben Sodium	INACTIVE INGREDIENT	625NNB0G9N	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Sorbitol	INACTIVE INGREDIENT	506T60A25R	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51460-1112	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS, INC.]	3	Legacy NDC, 12 package rows	20150127_018990a8-bcc7-43f9-928e-db937f5705bc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	018990a8-bcc7-43f9-928e-db937f5705bc	3
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	018990a8-bcc7-43f9-928e-db937f5705bc	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	018990a8-bcc7-43f9-928e-db937f5705bc	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	018990a8-bcc7-43f9-928e-db937f5705bc	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	018990a8-bcc7-43f9-928e-db937f5705bc	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	018990a8-bcc7-43f9-928e-db937f5705bc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51460-1112-0	51460111200	142 g in 1 TUBE	142 g	Historical
51460-1112-1	51460111201	85 g in 1 TUBE	85 g	Historical
51460-1112-2	51460111202	7.1 g in 1 PACKET	7.1 g	Historical
51460-1112-3	51460111203	85 g in 1 TUBE	85 g	Historical
51460-1112-4	51460111204	17 g in 1 TUBE	17 g	Historical
51460-1112-5	51460111205	24 g in 1 TUBE	24 g	Historical
51460-1112-6	51460111206	43 g in 1 TUBE	43 g	Historical
51460-1112-7	51460111207	1 in 1 BOX		Historical
51460-1112-8	51460111208	130 g in 1 TUBE	130 g	Historical
51460-1112-9	51460111209	181 g in 1 TUBE	181 g	Historical