UPC 801803 00211 MegaFresh Gel Fluoride Tooth

Product NDC: 54157-109
11-digit product format: 541570109
Labeler code: 54157
Product ID: 54157-109_298788aa-35a5-48f2-acad-c2187917f047
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
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 FLUORIDE
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	54157-109		I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-01	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-02	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-03	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-04	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-05	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-06	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-07	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-08	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-109	54157-109-09	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 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	54157-109-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-109-01	`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	54157-109-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-109-01	`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	54157-109-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-109-01	`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	54157-109-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54157-109-01	`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	54157-109-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54157-109-01	`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	54157-109-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54157-109-01	`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
54157-109-01	42824602-9b12-449d-9888-ade5a97ce129
54157-109-02	42824602-9b12-449d-9888-ade5a97ce129
54157-109-03	42824602-9b12-449d-9888-ade5a97ce129
54157-109-04	42824602-9b12-449d-9888-ade5a97ce129
54157-109-05	42824602-9b12-449d-9888-ade5a97ce129
54157-109-06	42824602-9b12-449d-9888-ade5a97ce129
54157-109-07	42824602-9b12-449d-9888-ade5a97ce129
54157-109-08	42824602-9b12-449d-9888-ade5a97ce129
54157-109-09	42824602-9b12-449d-9888-ade5a97ce129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54157-109-01	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	17 g in 1 TUBE	PASTE, DENTIFRICE	17	1
54157-109-02	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
54157-109-03	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	43 g in 1 TUBE	PASTE, DENTIFRICE	43	1
54157-109-04	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	78 g in 1 TUBE	PASTE, DENTIFRICE	78	1
54157-109-05	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	85 g in 1 TUBE	PASTE, DENTIFRICE	85	1
54157-109-06	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	130 g in 1 TUBE	PASTE, DENTIFRICE	130	1
54157-109-07	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	181 g in 1 TUBE	PASTE, DENTIFRICE	181	1
54157-109-08	UPC 801803 00211 MegaFresh Gel Fluoride Tooth	200 g in 1 TUBE	PASTE, DENTIFRICE	200	1
54157-109-09	UPC 801803 00211 MegaFresh Gel 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
54157-109	UPC 801803 00211 MEGAFRESH GEL FLUORIDE TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	1	Legacy NDC, 9 package rows	20170629_42824602-9b12-449d-9888-ade5a97ce129.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54157-109-01	54157010901	17 g in 1 TUBE	17 g	Historical
54157-109-02	54157010902	24 g in 1 TUBE	24 g	Historical
54157-109-03	54157010903	43 g in 1 TUBE	43 g	Historical
54157-109-04	54157010904	78 g in 1 TUBE	78 g	Historical
54157-109-05	54157010905	85 g in 1 TUBE	85 g	Historical
54157-109-06	54157010906	130 g in 1 TUBE	130 g	Historical
54157-109-07	54157010907	181 g in 1 TUBE	181 g	Historical
54157-109-08	54157010908	200 g in 1 TUBE	200 g	Historical
54157-109-09	54157010909	4.25 g in 1 POUCH	4.25 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UPC 801803 00211 MegaFresh Gel Fluoride Tooth - American Amenities, Inc.	American Amenities, Inc.	2017-06-03	HUMAN OTC DRUG LABEL	1