FLUORITAB CHEWABLE

Product NDC: 0288-1106
11-digit product format: 002881106
Labeler code: 0288
Product ID: 0288-1106_75d5beb2-d3d8-4e78-8df1-081095a53774
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Fluoritab Corporation
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-01-09
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 1 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0288-1106		I	Inactivated by FDA	2026-10-16
excluded package	package	0288-1106	0288-1106-01	I	Inactivated by FDA	2026-10-16
excluded package	package	0288-1106	0288-1106-02	I	Inactivated by FDA	2026-10-16
excluded package	package	0288-1106	0288-1106-10	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 2 · 88 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	0288-1106-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0288-1106-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0288-1106-02	`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	0288-1106-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0288-1106-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0288-1106-02	`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	0288-1106-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0288-1106-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0288-1106-02	`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	0288-1106-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0288-1106-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0288-1106-02	`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	0288-1106-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0288-1106-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0288-1106-02	`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	0288-1106-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0288-1106-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0288-1106-02	`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	0288-1106-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0288-1106-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0288-1106-02	`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	0288-1106-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0288-1106-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0288-1106-02	`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	0288-1106-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0288-1106-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0288-1106-02	`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	0288-1106-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0288-1106-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0288-1106-02	`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	0288-1106-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0288-1106-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0288-1106-02	`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	0288-1106-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0288-1106-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0288-1106-02	`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	0288-1106-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0288-1106-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0288-1106-02	`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	0288-1106-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0288-1106-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0288-1106-02	`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	0288-1106-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0288-1106-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0288-1106-02	`1332a3947898…`	`d4bfe170f9cd…`

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
0288-1106-01	2019-11-27	C162847	48780-1	9855d018-e82e-cd31-e053-dbdaa90ab51a	77785440-368b-4c4f-ae52-c0384a9c3bf2
0288-1106-02	2019-11-27	C162847	48780-1	9855d018-e82e-cd31-e053-dbdaa90ab51a	77785440-368b-4c4f-ae52-c0384a9c3bf2
0288-1106-10	2019-11-27	C162847	48780-1	9855d018-e82e-cd31-e053-dbdaa90ab51a	77785440-368b-4c4f-ae52-c0384a9c3bf2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0288-1106-01	FLUORITAB CHEWABLECHERRY	100 in 1 BOTTLE	TABLET, CHEWABLE	100	2
0288-1106-02	FLUORITAB CHEWABLECHERRY	5000 in 1 BOTTLE	TABLET, CHEWABLE	5000	2
0288-1106-10	FLUORITAB CHEWABLECHERRY	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0288-1106-01	EA - Each	0288-1106	5fd36aeb-c7ce-43a5-8dd8-b8a56d8588a3	1	2013-02-13
0288-1106-02	EA - Each	0288-1106	c02f4574-2d29-4b47-a128-6d928ea1d7ba	1	2013-02-13
0288-1106-10	EA - Each	0288-1106	01dd362b-8e16-4a56-abb9-d03ce0cb1d38	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]	2
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0288-1106	FLUORITAB CHEWABLE CHERRY (SODIUM FLUORIDE) TABLET, CHEWABLE [FLUORITAB CORPORATION]	2	Legacy NDC, 3 package rows	20121029_77785440-368b-4c4f-ae52-c0384a9c3bf2.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
861724	Fluoritab 1.1 MG Chewable Tablet	PSN	77785440-368b-4c4f-ae52-c0384a9c3bf2	2
313036	sodium fluoride 1.1 MG Chewable Tablet	PSN	77785440-368b-4c4f-ae52-c0384a9c3bf2	2
861724	sodium fluoride 1.1 MG Chewable Tablet [Fluoritab]	SBD	77785440-368b-4c4f-ae52-c0384a9c3bf2	2
313036	sodium fluoride 1.1 MG Chewable Tablet	SCD	77785440-368b-4c4f-ae52-c0384a9c3bf2	2
861724	Fluoritab 1.1 MG (fluoride 0.5 MG) Chewable Tablet	SY	77785440-368b-4c4f-ae52-c0384a9c3bf2	2
861724	Fluoritab 1.1 MG Chewable Tablet	SY	77785440-368b-4c4f-ae52-c0384a9c3bf2	2
313036	sodium fluoride 1.1 MG (fluoride ion 0.5 MG) Chewable Tablet	SY	77785440-368b-4c4f-ae52-c0384a9c3bf2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0288-1106-01	00288110601	100 in 1 BOTTLE	Historical
0288-1106-02	00288110602	5000 in 1 BOTTLE	Historical
0288-1106-10	00288110610	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM FLUORIDE - Fluoritab Corporation \| Medical Products Laboratories	Fluoritab Corporation \| Medical Products Laboratories	2012-10-29	HUMAN PRESCRIPTION DRUG LABEL	2