MegaFresh Fluoride Tooth

Product NDC: 54157-103
11-digit product format: 541570103
Labeler code: 54157
Product ID: 54157-103_def7e93e-088f-45ca-90bd-8146eda23abb
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: 2013-11-04
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 · 21 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54157-103		I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-01	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-02	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-03	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-04	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-05	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-06	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-07	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-08	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-09	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-10	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-11	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-12	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-13	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-14	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-15	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-16	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-17	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-18	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-19	I	Inactivated by FDA	2026-10-20
excluded package	package	54157-103	54157-103-20	I	Inactivated by FDA	2026-10-20

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 8 · 462 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	54157-103-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-103-09	`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	54157-103-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-103-09	`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	54157-103-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-103-14	`2ef7874e63bc…`	`57b86245f4fa…`

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
54157-103-01	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-02	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-03	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-04	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-05	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-06	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-07	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-08	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-09	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-10	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-11	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-12	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-13	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-14	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-15	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-16	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-17	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-18	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-19	c40be43e-3da9-441b-8cde-82a471b94012
54157-103-20	c40be43e-3da9-441b-8cde-82a471b94012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54157-103-01	MegaFresh Fluoride Tooth	17 g in 1 TUBE	PASTE, DENTIFRICE	17	4
54157-103-02	MegaFresh Fluoride Tooth	24 g in 1 TUBE	PASTE, DENTIFRICE	24	4
54157-103-03	MegaFresh Fluoride Tooth	35 g in 1 TUBE	PASTE, DENTIFRICE	35	4
54157-103-04	MegaFresh Fluoride Tooth	43 g in 1 TUBE	PASTE, DENTIFRICE	43	4
54157-103-05	MegaFresh Fluoride Tooth	50 g in 1 TUBE	PASTE, DENTIFRICE	50	4
54157-103-06	MegaFresh Fluoride Tooth	70 g in 1 TUBE	PASTE, DENTIFRICE	70	4
54157-103-07	MegaFresh Fluoride Tooth	78 g in 1 TUBE	PASTE, DENTIFRICE	78	4
54157-103-08	MegaFresh Fluoride Tooth	90 g in 1 TUBE	PASTE, DENTIFRICE	90	4
54157-103-09	MegaFresh Fluoride Tooth	100 g in 1 TUBE	PASTE, DENTIFRICE	100	4
54157-103-10	MegaFresh Fluoride Tooth	120 g in 1 TUBE	PASTE, DENTIFRICE	120	4
54157-103-11	MegaFresh Fluoride Tooth	130 g in 1 TUBE	PASTE, DENTIFRICE	130	4
54157-103-12	MegaFresh Fluoride Tooth	150 g in 1 TUBE	PASTE, DENTIFRICE	150	4
54157-103-13	MegaFresh Fluoride Tooth	181 g in 1 TUBE	PASTE, DENTIFRICE	181	4
54157-103-14	MegaFresh Fluoride Tooth	200 g in 1 TUBE	PASTE, DENTIFRICE	200	4
54157-103-15	MegaFresh Fluoride Tooth	3 g in 1 POUCH	PASTE, DENTIFRICE	3	4
54157-103-16	MegaFresh Fluoride Tooth	5 g in 1 POUCH	PASTE, DENTIFRICE	5	4
54157-103-17	MegaFresh Fluoride Tooth	10 g in 1 POUCH	PASTE, DENTIFRICE	10	4
54157-103-18	MegaFresh Fluoride Tooth	4.25 g in 1 POUCH	PASTE, DENTIFRICE	4.25	4
54157-103-19	MegaFresh Fluoride Tooth	71 g in 1 TUBE	PASTE, DENTIFRICE	71	4
54157-103-20	MegaFresh Fluoride Tooth	85 g in 1 TUBE	PASTE, DENTIFRICE	85	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54157-103	MEGAFRESH FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AMENITIES, INC.]	4	Legacy NDC, 20 package rows	20150120_c40be43e-3da9-441b-8cde-82a471b94012.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	c40be43e-3da9-441b-8cde-82a471b94012	4
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	c40be43e-3da9-441b-8cde-82a471b94012	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	c40be43e-3da9-441b-8cde-82a471b94012	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	c40be43e-3da9-441b-8cde-82a471b94012	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	c40be43e-3da9-441b-8cde-82a471b94012	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	c40be43e-3da9-441b-8cde-82a471b94012	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54157-103-01	54157010301	17 g in 1 TUBE	17 g	Historical
54157-103-02	54157010302	24 g in 1 TUBE	24 g	Historical
54157-103-03	54157010303	35 g in 1 TUBE	35 g	Historical
54157-103-04	54157010304	43 g in 1 TUBE	43 g	Historical
54157-103-05	54157010305	50 g in 1 TUBE	50 g	Historical
54157-103-06	54157010306	70 g in 1 TUBE	70 g	Historical
54157-103-07	54157010307	78 g in 1 TUBE	78 g	Historical
54157-103-08	54157010308	90 g in 1 TUBE	90 g	Historical
54157-103-09	54157010309	100 g in 1 TUBE	100 g	Historical
54157-103-10	54157010310	120 g in 1 TUBE	120 g	Historical
54157-103-11	54157010311	130 g in 1 TUBE	130 g	Historical
54157-103-12	54157010312	150 g in 1 TUBE	150 g	Historical
54157-103-13	54157010313	181 g in 1 TUBE	181 g	Historical
54157-103-14	54157010314	200 g in 1 TUBE	200 g	Historical
54157-103-15	54157010315	3 g in 1 POUCH	3 g	Historical
54157-103-16	54157010316	5 g in 1 POUCH	5 g	Historical
54157-103-17	54157010317	10 g in 1 POUCH	10 g	Historical
54157-103-18	54157010318	4.25 g in 1 POUCH	4.25 g	Historical
54157-103-19	54157010319	71 g in 1 TUBE	71 g	Historical
54157-103-20	54157010320	85 g in 1 TUBE	85 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MegaFresh Fluoride Tooth - American Amenities, Inc.	American Amenities, Inc.	2015-01-16	HUMAN OTC DRUG LABEL	4