Simply White

Product NDC: 51009-148
11-digit product format: 510090148
Labeler code: 51009
Product ID: 51009-148_2aae47ad-fe31-4232-b786-bf5cf28f5fe0
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Tom's of Maine, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-02-04
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51009-148		I	Inactivated by FDA	2026-10-05
excluded package	package	51009-148	51009-148-01	I	Inactivated by FDA	2026-10-05
excluded package	package	51009-148	51009-148-47	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 2 · 66 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	51009-148-47	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51009-148-01	`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	51009-148-47	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51009-148-01	`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	51009-148-47	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51009-148-01	`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	51009-148-47	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51009-148-01	`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	51009-148-47	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51009-148-01	`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	51009-148-47	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51009-148-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51009-148-47	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51009-148-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51009-148-47	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51009-148-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51009-148-47	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51009-148-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51009-148-47	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51009-148-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51009-148-47	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51009-148-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51009-148-47	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51009-148-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51009-148-47	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51009-148-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51009-148-47	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51009-148-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51009-148-47	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51009-148-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51009-148-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51009-148-47	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51009-148-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51009-148-47	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51009-148-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51009-148-47	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51009-148-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51009-148-47	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51009-148-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51009-148-47	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51009-148-01	2020-01-31	C162847	48780-1	9d75b9d0-035b-f424-e053-dadaa90a57ce	SIMPLY WHITE ®
51009-148-47	2020-01-31	C162847	48780-1	9d75b9d0-035b-f424-e053-dadaa90a57ce	SIMPLY WHITE ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51009-148-01	Simply Whiteclean mint	25 g in 1 TUBE	PASTE, DENTIFRICE	25	2
51009-148-01	Simply Whiteclean mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	2
51009-148-47	Simply Whiteclean mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	2
51009-148-47	Simply Whiteclean mint	133.2 g in 1 TUBE	PASTE, DENTIFRICE	133.2	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
fluoride ion	ACTIVE MOIETY	Q80VPU408O	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Menthol	INACTIVE INGREDIENT	L7T10EIP3A	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Spearmint oil	INACTIVE INGREDIENT	C3M81465G5	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51009-148	SIMPLY WHITE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	2	Legacy NDC, 4 package rows	20110323_350597b0-c2a0-4d9a-89d3-4c5930f4909c.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
416783	sodium fluoride 0.24 % Toothpaste	PSN	350597b0-c2a0-4d9a-89d3-4c5930f4909c	2
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	350597b0-c2a0-4d9a-89d3-4c5930f4909c	2
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	350597b0-c2a0-4d9a-89d3-4c5930f4909c	2
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	350597b0-c2a0-4d9a-89d3-4c5930f4909c	2
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	350597b0-c2a0-4d9a-89d3-4c5930f4909c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51009-148-01	51009014801	25 g in 1 TUBE	25 g	Historical
51009-148-47	51009014847	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIMPLY WHITE ®	Tom's of Maine, Inc. \| Colgate-Palmolive Canada, Inc.	2011-02-03	HUMAN OTC DRUG LABEL	2