CLOSE UP

Product NDC: 10237-644
11-digit product format: 102370644
Labeler code: 10237
Product ID: 10237-644_3e62cc44-3168-5e02-e063-6294a90a129d
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Church & Dwight Co., Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2001-03-01
Substance: SODIUM FLUORIDE
Active strength: 2.4 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10237-644	10237-644-72	D	Discontinued by firm		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 · 20 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	10237-644-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	10237-644-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	10237-644-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	10237-644-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	10237-644-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	10237-644-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	10237-644-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	10237-644-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	10237-644-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	10237-644-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	10237-644-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	10237-644-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	10237-644-72	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	10237-644-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	10237-644-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	10237-644-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	10237-644-72	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	10237-644-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	10237-644-72	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	10237-644-72	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CLOSE UP
Brand name suffix: Freshening with Mouthwash
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	2.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416783	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e660b0d7-4cc5-4028-bdf5-016b85899728	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10237-644-40	CLOSE UPFreshening with Mouthwash	1 in 1 CARTON	GEL, DENTIFRICE	1	11
10237-644-40	CLOSE UPFreshening with Mouthwash	113.4 g in 1 TUBE	GEL, DENTIFRICE	113.4	11
10237-644-60	CLOSE UPFreshening with Mouthwash	170 g in 1 TUBE	GEL, DENTIFRICE	170	11
10237-644-60	CLOSE UPFreshening with Mouthwash	1 in 1 CARTON	GEL, DENTIFRICE	1	11
10237-644-72	CLOSE UPFreshening with Mouthwash	204 g in 1 TUBE	GEL, DENTIFRICE	204	11
10237-644-72	CLOSE UPFreshening with Mouthwash	1 in 1 CARTON	GEL, DENTIFRICE	1	11
10237-644-80	CLOSE UPFreshening with Mouthwash	1 in 1 CARTON	GEL, DENTIFRICE	1	11
10237-644-80	CLOSE UPFreshening with Mouthwash	226.8 g in 1 TUBE	GEL, DENTIFRICE	226.8	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
PEG-8 STEARATE	INACTIVE INGREDIENT	2P9L47VI5E	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-644	CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]	10	Current NDC, Legacy NDC, 8 package rows	20241123_e660b0d7-4cc5-4028-bdf5-016b85899728.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 31 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba491f4-2ad2-6e7b-e063-6394a90a9fb7	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188ac743-3ba8-4da4-e063-6294a90a8f87	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b682604-c563-01f1-e063-6294a90ab0bd	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b110db1-fcc0-377f-e063-6394a90a4d44	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74ecc4-a1e6-348f-e063-6294a90a5894	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b68315c-6afa-3f37-e063-6294a90a14e8	2025-12-11	Warnings	Exact identifier application number: M021
ANTICAVITY FLUORIDE	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	295b88e8-c4b5-c0b0-e063-6394a90aca01	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74f072-c33b-c6e2-e063-6394a90ab1e6	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba4a807-d6d5-04a0-e063-6294a90ae04d	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b617f4a-b56c-9f75-e063-6294a90a7abe	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b9ec370-eadf-92c4-e063-6294a90a9055	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1eb04296-ecb1-3ccc-e063-6294a90a9bda	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b9e7b21-0d34-74ec-e063-6294a90a1f59	2025-12-11		Exact identifier application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	28986d7f-3e9a-8dfb-e063-6394a90a731e	2025-12-10	Warnings	Exact identifier application number: M021
Toms of Maine Tropical Island	ALUMINUM CHLOROHYDRATE	Colgate-Palmolive Company	0d6c51bc-5391-4533-b4fd-961dc4f36342	2025-12-10	Warnings	Exact identifier application number: M021
Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	483d7aec-34ac-49c5-ac0e-8fba5b4737ae	2025-12-09	Warnings	Exact identifier application number: M021
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	121decce-c364-4060-87da-0c6a6cd48474	2025-12-08	Warnings	Exact identifier application number: M021
First Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	ba717de8-c3a2-41bf-85a1-aa75f9744d30	2025-12-08	Warnings	Exact identifier application number: M021
United Airlines Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	United Airlines	94c5e9a4-19f3-4590-9da4-313c75261231	2025-12-08	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	5f08d994-e458-42b2-aa39-e84fca3acf48	2025-12-05	Warnings	Exact identifier application number: M021

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	e660b0d7-4cc5-4028-bdf5-016b85899728	11
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	e660b0d7-4cc5-4028-bdf5-016b85899728	11
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	e660b0d7-4cc5-4028-bdf5-016b85899728	11
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	e660b0d7-4cc5-4028-bdf5-016b85899728	11
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	e660b0d7-4cc5-4028-bdf5-016b85899728	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10237-644-40	10237064440	1 TUBE in 1 CARTON (10237-644-40) / 113.4 g in 1 TUBE	1 tube	2001-03-01	0000-00-00	No	No	Current
10237-644-60	10237064460	1 TUBE in 1 CARTON (10237-644-60) / 170 g in 1 TUBE	1 tube	2001-03-01	0000-00-00	No	No	Current
10237-644-72	10237064472	1 TUBE in 1 CARTON (10237-644-72) > 204 g in 1 TUBE	1 tube	2001-03-01	0000-00-00	No	No	Current
10237-644-80	10237064480	1 TUBE in 1 CARTON (10237-644-80) / 226.8 g in 1 TUBE	1 tube	2001-03-01	0000-00-00	No	No	Current