Whole Care

Product NDC: 51009-105
11-digit product format: 510090105
Labeler code: 51009
Product ID: 51009-105_3452f64a-225d-428c-95d3-df5bd9c8d826
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium monofluorophosphate
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Tom's of Maine, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-02-14
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51009-105		I	Inactivated by FDA		2026-10-05
excluded package	package	51009-105	51009-105-47	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 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51009-105-47	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51009-105-47	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51009-105-47	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51009-105-47	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51009-105-47	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51009-105-47	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51009-105-47	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51009-105-47	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51009-105-47	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51009-105-47	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51009-105-47	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51009-105-47	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51009-105-47	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51009-105-47	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51009-105-47	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51009-105-47	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51009-105-47	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51009-105-47	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51009-105-47	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51009-105-47	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	51009-105-47	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	51009-105-47	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
51009-105-47	2020-01-31	C162847	48780-1	9d75b9cf-f863-f424-e053-dadaa90a57ce	Tom's OF MAINE WHOLE CARE fluoride toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51009-105-47	Whole Care Spearmint	1 in 1 CARTON	PASTE, DENTIFRICE	1		1
51009-105-47	Whole Care Spearmint	133 g in 1 TUBE	PASTE, DENTIFRICE	133		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
fluoride ion	ACTIVE MOIETY	Q80VPU408O	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Calcium carbonate	INACTIVE INGREDIENT	H0G9379FGK	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Cinnamon leaf oil	INACTIVE INGREDIENT	S92U8SQ71V	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Clove oil	INACTIVE INGREDIENT	578389D6D0	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Clove stem oil	INACTIVE INGREDIENT	9368YZM9M4	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Methyl salicylate	INACTIVE INGREDIENT	LAV5U5022Y	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Spearmint Oil	INACTIVE INGREDIENT	C3M81465G5	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1
Zinc citrate	INACTIVE INGREDIENT	K72I3DEX9B	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51009-105	WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]	1	Legacy NDC, 2 package rows	20110222_7f20f8a0-75f9-4365-b00a-a53c6a35b448.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	7f20f8a0-75f9-4365-b00a-a53c6a35b448	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	7f20f8a0-75f9-4365-b00a-a53c6a35b448	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	7f20f8a0-75f9-4365-b00a-a53c6a35b448	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	7f20f8a0-75f9-4365-b00a-a53c6a35b448	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	7f20f8a0-75f9-4365-b00a-a53c6a35b448	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	7f20f8a0-75f9-4365-b00a-a53c6a35b448	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
51009-105-47	51009010547	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tom's OF MAINE WHOLE CARE fluoride toothpaste	Tom's of Maine, Inc.	2011-02-11	HUMAN OTC DRUG LABEL	1