MegaFresh

Product NDC: 54157-102
11-digit product format: 541570102
Labeler code: 54157
Product ID: 54157-102_1e9bad2c-9dd6-43ba-af20-9e7865d450ad
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: 2013-11-04
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	54157-102		I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-01	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-02	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-03	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-04	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-05	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-06	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-07	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-08	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-09	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-10	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-11	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-12	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-13	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-14	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-15	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-16	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-17	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-18	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-19	I	Inactivated by FDA	2026-10-16
excluded package	package	54157-102	54157-102-20	I	Inactivated by FDA	2026-10-16

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	54157-102-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54157-102-01	`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	54157-102-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54157-102-01	`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	54157-102-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54157-102-15	`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
54157-102-01	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-02	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-03	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-04	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-05	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-06	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-07	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-08	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-09	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-10	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-11	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-12	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-13	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-14	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-15	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-16	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-17	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-18	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-19	3ef5fc36-d922-4574-a280-a8ad4a1c763a
54157-102-20	3ef5fc36-d922-4574-a280-a8ad4a1c763a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54157-102-01	MegaFresh	17 g in 1 TUBE	GEL, DENTIFRICE	17	4
54157-102-02	MegaFresh	24 g in 1 TUBE	GEL, DENTIFRICE	24	4
54157-102-03	MegaFresh	35 g in 1 TUBE	GEL, DENTIFRICE	35	4
54157-102-04	MegaFresh	43 g in 1 TUBE	GEL, DENTIFRICE	43	4
54157-102-05	MegaFresh	50 g in 1 TUBE	GEL, DENTIFRICE	50	4
54157-102-06	MegaFresh	70 g in 1 TUBE	GEL, DENTIFRICE	70	4
54157-102-07	MegaFresh	78 g in 1 TUBE	GEL, DENTIFRICE	78	4
54157-102-08	MegaFresh	90 g in 1 TUBE	GEL, DENTIFRICE	90	4
54157-102-09	MegaFresh	100 g in 1 TUBE	GEL, DENTIFRICE	100	4
54157-102-10	MegaFresh	120 g in 1 TUBE	GEL, DENTIFRICE	120	4
54157-102-11	MegaFresh	130 g in 1 TUBE	GEL, DENTIFRICE	130	4
54157-102-12	MegaFresh	150 g in 1 TUBE	GEL, DENTIFRICE	150	4
54157-102-13	MegaFresh	181 g in 1 TUBE	GEL, DENTIFRICE	181	4
54157-102-14	MegaFresh	200 g in 1 TUBE	GEL, DENTIFRICE	200	4
54157-102-15	MegaFresh	4.25 g in 1 POUCH	GEL, DENTIFRICE	4.25	4
54157-102-16	MegaFresh	3 g in 1 POUCH	GEL, DENTIFRICE	3	4
54157-102-17	MegaFresh	5 g in 1 POUCH	GEL, DENTIFRICE	5	4
54157-102-18	MegaFresh	10 g in 1 POUCH	GEL, DENTIFRICE	10	4
54157-102-19	MegaFresh	71 g in 1 TUBE	GEL, DENTIFRICE	71	4
54157-102-20	MegaFresh	85 g in 1 TUBE	GEL, DENTIFRICE	85	4

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54157-102	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	4	Legacy NDC, 20 package rows	20150120_3ef5fc36-d922-4574-a280-a8ad4a1c763a.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
245598	sodium fluoride 0.22 % Toothpaste	PSN	3ef5fc36-d922-4574-a280-a8ad4a1c763a	4
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	3ef5fc36-d922-4574-a280-a8ad4a1c763a	4
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	3ef5fc36-d922-4574-a280-a8ad4a1c763a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54157-102-01	54157010201	17 g in 1 TUBE	17 g	Historical
54157-102-02	54157010202	24 g in 1 TUBE	24 g	Historical
54157-102-03	54157010203	35 g in 1 TUBE	35 g	Historical
54157-102-04	54157010204	43 g in 1 TUBE	43 g	Historical
54157-102-05	54157010205	50 g in 1 TUBE	50 g	Historical
54157-102-06	54157010206	70 g in 1 TUBE	70 g	Historical
54157-102-07	54157010207	78 g in 1 TUBE	78 g	Historical
54157-102-08	54157010208	90 g in 1 TUBE	90 g	Historical
54157-102-09	54157010209	100 g in 1 TUBE	100 g	Historical
54157-102-10	54157010210	120 g in 1 TUBE	120 g	Historical
54157-102-11	54157010211	130 g in 1 TUBE	130 g	Historical
54157-102-12	54157010212	150 g in 1 TUBE	150 g	Historical
54157-102-13	54157010213	181 g in 1 TUBE	181 g	Historical
54157-102-14	54157010214	200 g in 1 TUBE	200 g	Historical
54157-102-15	54157010215	4.25 g in 1 POUCH	4.25 g	Historical
54157-102-16	54157010216	3 g in 1 POUCH	3 g	Historical
54157-102-17	54157010217	5 g in 1 POUCH	5 g	Historical
54157-102-18	54157010218	10 g in 1 POUCH	10 g	Historical
54157-102-19	54157010219	71 g in 1 TUBE	71 g	Historical
54157-102-20	54157010220	85 g in 1 TUBE	85 g	Historical