Plus White Xtra Whitening

Product NDC: 61543-7243
11-digit product format: 615437243
Labeler code: 61543
Product ID: 61543-7243_b00ec00f-3079-15a1-e053-2a95a90a879d
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE
Dosage form: PASTE
Route: DENTAL
Labeler: CCA Industries, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-06-11
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 2 mg/g
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61543-7243		I	Inactivated by FDA		2026-08-17
excluded package	package	61543-7243	61543-7243-3	I	Inactivated by FDA		2026-08-17

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 · 30 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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`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	61543-7243-3	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61543-7243-3	2024-01-30	C162847	48780-1	ab0e2407-2693-f274-e053-dbdaa90a6471	Plus White Xtra Whitening
61543-7243-3	2020-09-24	C162847	48780-1	ab0e2407-2693-f274-e053-dbdaa90a6471	Plus White Xtra Whitening
61543-7243-3	2020-07-22	C162847	48780-1	ab0e2407-2693-f274-e053-dbdaa90a6471	Plus White Xtra Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61543-7243-3	Plus White Xtra Whitening	1 in 1 BOX	PASTE	1		4
61543-7243-3	Plus White Xtra Whitening	100 g in 1 TUBE	PASTE	100		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61543-7243	PLUS WHITE XTRA WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]	4	Legacy NDC, 2 package rows	20200925_b3550c69-b79f-48e7-8d1e-85946a688de0.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
891795	sodium monofluorophosphate 0.884 % Toothpaste	PSN	b3550c69-b79f-48e7-8d1e-85946a688de0	4
891795	sodium monofluorophosphate 0.00884 MG/MG Toothpaste	SCD	b3550c69-b79f-48e7-8d1e-85946a688de0	4
891795	sodium monofluorophosphate 0.884 % Toothpaste	SY	b3550c69-b79f-48e7-8d1e-85946a688de0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61543-7243-3	61543724303	1 TUBE in 1 BOX (61543-7243-3) > 100 g in 1 TUBE	1 tube	2010-06-11	0000-00-00	No	No	Current