ACT Restoring Anticavity Fluoride Cool Mint

Product NDC: 41167-0981
11-digit product format: 411670981
Labeler code: 41167
Product ID: 41167-0981_125e5c98-dc8c-4b48-9b1c-7e6557d2ea96
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride
Dosage form: MOUTHWASH
Route: TOPICAL
Labeler: Chattem, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-02-01
Substance: SODIUM FLUORIDE
Active strength: .09 mg/mL
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	41167-0981	41167-0981-2	D	Discontinued by firm		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 · 12 matching rows.

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

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

Additional Listing Data#

Finished product: Yes
Brand name base: ACT Restoring Anticavity Fluoride Cool Mint
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.09 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313029	Internal RxNorm lookup
1044540	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
3409a749-4a1a-4950-8c21-364d1b977af7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41167-0981-2	ACT Restoring Anticavity Fluoride Cool Mint	1250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1250		14
41167-0981-7	ACT Restoring Anticavity Fluoride Cool Mint	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
EDETATE CALCIUM DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8U5D034955	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0981	ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20241004_3409a749-4a1a-4950-8c21-364d1b977af7.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 1 of 52 · 1,024 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	54bd43c9-489d-4e6b-9031-90ec0e3c4516	2026-09-01	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	53c344e9-49f5-48aa-8309-1e15f80b80a0	2026-09-01	Warnings	Exact identifier application number: M021
Silly Strawberry Anticavity - BFT51 MRT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	e36ceb7a-9a29-41d8-8d08-a859e515f1f5	2026-08-10	Warnings	Exact identifier application number: M021
Willo Minty Mist Dye Free	SODIUM FLUORIDE	Willo 32, Inc.	3ee5b49e-ca9a-ece6-e063-6394a90a3d00	2026-08-10	Warnings	Exact identifier application number: M021
Willo Bubble Twist	SODIUM FLUORIDE	Willo 32 Inc	36560d62-e901-1f93-e063-6394a90a2803	2026-08-10	Warnings	Exact identifier application number: M021
Willo Berry Splash Dye Free	SODIUM FLUORIDE	Willo 32, Inc	3ea91af9-2895-e530-e063-6394a90a39e5	2026-08-10	Warnings	Exact identifier application number: M021
Fluoride Mouth Rinse Anticavity	SODIUM FLUORIDE	Target Corporation	3daf3cc3-585a-4bb2-9b56-7117d220ed38	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEAN	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	b1ada157-a9a0-4eec-83a2-6e448d7f12dc	2026-08-07	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	188dc3ac-64c9-438e-858b-846f725c6ea0	2026-08-07	Warnings	Exact identifier application number: M021
Colgate Optic White Stain Fighter With Baking Soda	SODIUM FLUORIDE	Colgate-Palmolive Company	8e6113e2-101b-4bde-90e9-6ab32c6ebf5c	2026-08-05	Warnings	Exact identifier application number: M021
TOTAL TP CLEAN MINT PST	STANNOUS FLUORIDE	Colgate-Palmolive Company	178d4535-fa57-4b53-b1f8-5c591f2ea9e7	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd954777-697a-4cc7-8f5f-b2caf357ef95	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH WATERMELON BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6c391ef3-d625-403c-a4dc-6e2212682ed1	2026-08-04	Warnings	Exact identifier application number: M021
COLGATE 2 IN 1 KIDS SP STRAWBERRY	SODIUM FLUORIDE	Colgate-Palmolive Company	d037f65c-3d22-4d2a-a0a9-3dcba2357ebd	2026-08-04	Warnings	Exact identifier application number: M021
Colgate ULTRA BRITE Baking Soda and Peroxide Whitening	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	2b123d70-4f7d-41b0-b48f-711999e97ee0	2026-08-04	Warnings	Exact identifier application number: M021
Rorobell WaWa Tooth	SODIUM MONOFLUOROPHOSPHATE	ROROBELL	93113481-ad9d-4be0-a7b7-a72c8726127d	2026-08-03	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE CHARCOAL	SODIUM FLUORIDE	Colgate-Palmolive Company	70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2	2026-07-30	Warnings	Exact identifier application number: M021
Colgate Optic White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	82ac5b9d-19e8-46ac-a195-c7d85f2967d5	2026-07-30	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	251264ea-20d2-be19-e063-6394a90aa5f6	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Sensitive Enamel Guard Alpine Mint	SODIUM FLUORIDE	Lornamead Products	2e832204-ba2d-6dcb-e063-6394a90a5e6c	2026-07-29	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
1044540	ACT 0.02 % (fluoride ion 0.009 % ) Mouthwash	PSN	3409a749-4a1a-4950-8c21-364d1b977af7	14
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	3409a749-4a1a-4950-8c21-364d1b977af7	14
1044540	sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]	SBD	3409a749-4a1a-4950-8c21-364d1b977af7	14
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	3409a749-4a1a-4950-8c21-364d1b977af7	14
1044540	ACT Braces Care 0.02 % Mouthwash	SY	3409a749-4a1a-4950-8c21-364d1b977af7	14
1044540	ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) Mouthwash	SY	3409a749-4a1a-4950-8c21-364d1b977af7	14
1044540	ACT Fluoride Rinse 0.2 MG/ML Mouthwash	SY	3409a749-4a1a-4950-8c21-364d1b977af7	14
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	3409a749-4a1a-4950-8c21-364d1b977af7	14
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	3409a749-4a1a-4950-8c21-364d1b977af7	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-0981-2	41167098102	1250 mL in 1 BOTTLE, PLASTIC	1250 ml					Historical
41167-0981-7	41167098107	1000 mL in 1 BOTTLE, PLASTIC (41167-0981-7)	1000 ml	2006-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACT Restoring Anticavity Fluoride Mouthwash Cool Mint	Chattem, Inc.	2025-07-22	HUMAN OTC DRUG LABEL	14