MegaFresh

Product NDC: 54157-104
11-digit product format: 541570104
Labeler code: 54157
Product ID: 54157-104_b64481d2-6ade-4eeb-b267-667e1085f1c0
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: American Amenities, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-05-11
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 · 21 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54157-104		I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-01	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-02	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-03	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-04	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-05	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-06	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-07	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-08	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-09	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-10	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-11	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-12	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-13	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-14	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-15	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-16	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-17	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-18	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-19	I	Inactivated by FDA	2026-10-05
excluded package	package	54157-104	54157-104-20	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 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	54157-104-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-104-02	`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	54157-104-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-104-02	`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	54157-104-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-104-15	`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
54157-104-01	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-02	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-03	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-04	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-05	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-06	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-07	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-08	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-09	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-10	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-11	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-12	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-13	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-14	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-15	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-16	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-17	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-18	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-19	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-20	803ebf8d-32bd-4060-b51b-88fca0a5ccee

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54157-104-01	MegaFresh	17 g in 1 TUBE	GEL, DENTIFRICE	17	3
54157-104-02	MegaFresh	24 g in 1 TUBE	GEL, DENTIFRICE	24	3
54157-104-03	MegaFresh	35 g in 1 TUBE	GEL, DENTIFRICE	35	3
54157-104-04	MegaFresh	43 g in 1 TUBE	GEL, DENTIFRICE	43	3
54157-104-05	MegaFresh	50 g in 1 TUBE	GEL, DENTIFRICE	50	3
54157-104-06	MegaFresh	70 g in 1 TUBE	GEL, DENTIFRICE	70	3
54157-104-07	MegaFresh	78 g in 1 TUBE	GEL, DENTIFRICE	78	3
54157-104-08	MegaFresh	90 g in 1 TUBE	GEL, DENTIFRICE	90	3
54157-104-09	MegaFresh	100 g in 1 TUBE	GEL, DENTIFRICE	100	3
54157-104-10	MegaFresh	120 g in 1 TUBE	GEL, DENTIFRICE	120	3
54157-104-11	MegaFresh	130 g in 1 TUBE	GEL, DENTIFRICE	130	3
54157-104-12	MegaFresh	150 g in 1 TUBE	GEL, DENTIFRICE	150	3
54157-104-13	MegaFresh	181 g in 1 TUBE	GEL, DENTIFRICE	181	3
54157-104-14	MegaFresh	200 g in 1 TUBE	GEL, DENTIFRICE	200	3
54157-104-15	MegaFresh	4.25 g in 1 POUCH	GEL, DENTIFRICE	4.25	3
54157-104-16	MegaFresh	3 g in 1 POUCH	GEL, DENTIFRICE	3	3
54157-104-17	MegaFresh	5 g in 1 POUCH	GEL, DENTIFRICE	5	3
54157-104-18	MegaFresh	10 g in 1 POUCH	GEL, DENTIFRICE	10	3
54157-104-19	MegaFresh	71 g in 1 TUBE	GEL, DENTIFRICE	71	3
54157-104-20	MegaFresh	85 g in 1 TUBE	GEL, DENTIFRICE	85	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54157-104	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3	Legacy NDC, 20 package rows	20150120_803ebf8d-32bd-4060-b51b-88fca0a5ccee.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
891775	sodium fluoride 0.243 % Toothpaste	PSN	803ebf8d-32bd-4060-b51b-88fca0a5ccee	3
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	803ebf8d-32bd-4060-b51b-88fca0a5ccee	3
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	803ebf8d-32bd-4060-b51b-88fca0a5ccee	3
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	803ebf8d-32bd-4060-b51b-88fca0a5ccee	3
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	803ebf8d-32bd-4060-b51b-88fca0a5ccee	3
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	803ebf8d-32bd-4060-b51b-88fca0a5ccee	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54157-104-01	54157010401	17 g in 1 TUBE	17 g	Historical
54157-104-02	54157010402	24 g in 1 TUBE	24 g	Historical
54157-104-03	54157010403	35 g in 1 TUBE	35 g	Historical
54157-104-04	54157010404	43 g in 1 TUBE	43 g	Historical
54157-104-05	54157010405	50 g in 1 TUBE	50 g	Historical
54157-104-06	54157010406	70 g in 1 TUBE	70 g	Historical
54157-104-07	54157010407	78 g in 1 TUBE	78 g	Historical
54157-104-08	54157010408	90 g in 1 TUBE	90 g	Historical
54157-104-09	54157010409	100 g in 1 TUBE	100 g	Historical
54157-104-10	54157010410	120 g in 1 TUBE	120 g	Historical
54157-104-11	54157010411	130 g in 1 TUBE	130 g	Historical
54157-104-12	54157010412	150 g in 1 TUBE	150 g	Historical
54157-104-13	54157010413	181 g in 1 TUBE	181 g	Historical
54157-104-14	54157010414	200 g in 1 TUBE	200 g	Historical
54157-104-15	54157010415	4.25 g in 1 POUCH	4.25 g	Historical
54157-104-16	54157010416	3 g in 1 POUCH	3 g	Historical
54157-104-17	54157010417	5 g in 1 POUCH	5 g	Historical
54157-104-18	54157010418	10 g in 1 POUCH	10 g	Historical
54157-104-19	54157010419	71 g in 1 TUBE	71 g	Historical
54157-104-20	54157010420	85 g in 1 TUBE	85 g	Historical