UPC 801803 00203 MegaFresh Fluoride Tooth

Product NDC: 54157-108
11-digit product format: 541570108
Labeler code: 54157
Product ID: 54157-108_e2a1fbd5-d2e1-4ae0-b24f-47e8e0da6396
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: American Amenities, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-06-03
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 0 g/100g
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54157-108		I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-01	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-02	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-03	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-04	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-05	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-06	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-07	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-08	I	Inactivated by FDA	2026-10-12
excluded package	package	54157-108	54157-108-09	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 4 · 220 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	54157-108-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-108-05	`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	54157-108-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-108-05	`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	54157-108-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-108-05	`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	54157-108-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-108-05	`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	54157-108-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-108-05	`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	54157-108-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-108-05	`cdf11ea48f46…`	`ba0047e9e063…`

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
54157-108-01	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-02	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-03	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-04	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-05	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-06	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-07	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-08	6d23604c-0749-4bb3-a405-c2bd06d9318c
54157-108-09	6d23604c-0749-4bb3-a405-c2bd06d9318c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54157-108-01	UPC 801803 00203 MegaFresh Fluoride Tooth	17 g in 1 TUBE	PASTE, DENTIFRICE	17	1
54157-108-02	UPC 801803 00203 MegaFresh Fluoride Tooth	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
54157-108-03	UPC 801803 00203 MegaFresh Fluoride Tooth	43 g in 1 TUBE	PASTE, DENTIFRICE	43	1
54157-108-04	UPC 801803 00203 MegaFresh Fluoride Tooth	78 g in 1 TUBE	PASTE, DENTIFRICE	78	1
54157-108-05	UPC 801803 00203 MegaFresh Fluoride Tooth	85 g in 1 TUBE	PASTE, DENTIFRICE	85	1
54157-108-06	UPC 801803 00203 MegaFresh Fluoride Tooth	130 g in 1 TUBE	PASTE, DENTIFRICE	130	1
54157-108-07	UPC 801803 00203 MegaFresh Fluoride Tooth	181 g in 1 TUBE	PASTE, DENTIFRICE	181	1
54157-108-08	UPC 801803 00203 MegaFresh Fluoride Tooth	200 g in 1 TUBE	PASTE, DENTIFRICE	200	1
54157-108-09	UPC 801803 00203 MegaFresh Fluoride Tooth	4.25 g in 1 POUCH	PASTE, DENTIFRICE	4.25	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54157-108	UPC 801803 00203 MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	1	Legacy NDC, 9 package rows	20170629_6d23604c-0749-4bb3-a405-c2bd06d9318c.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
1091932	sodium monofluorophosphate 0.1 % Toothpaste	PSN	6d23604c-0749-4bb3-a405-c2bd06d9318c	1
1091932	sodium monofluorophosphate 0.001 MG/MG Toothpaste	SCD	6d23604c-0749-4bb3-a405-c2bd06d9318c	1
1091932	sodium monofluorophosphate 0.1 % Toothpaste	SY	6d23604c-0749-4bb3-a405-c2bd06d9318c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54157-108-01	54157010801	17 g in 1 TUBE	17 g	Historical
54157-108-02	54157010802	24 g in 1 TUBE	24 g	Historical
54157-108-03	54157010803	43 g in 1 TUBE	43 g	Historical
54157-108-04	54157010804	78 g in 1 TUBE	78 g	Historical
54157-108-05	54157010805	85 g in 1 TUBE	85 g	Historical
54157-108-06	54157010806	130 g in 1 TUBE	130 g	Historical
54157-108-07	54157010807	181 g in 1 TUBE	181 g	Historical
54157-108-08	54157010808	200 g in 1 TUBE	200 g	Historical
54157-108-09	54157010809	4.25 g in 1 POUCH	4.25 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UPC 801803 00203 MegaFresh Fluoride Tooth - American Amenities, Inc.	American Amenities, Inc.	2017-06-03	HUMAN OTC DRUG LABEL	1