ACT Restoring Anticavity Fluoride Mint Burst

Product NDC: 41167-0979
11-digit product format: 411670979
Labeler code: 41167
Product ID: 41167-0979_c8d906b9-c4c5-425f-8955-e3b451311e74
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium fluoride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Chattem, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-12-16
Substance: SODIUM FLUORIDE
Active strength: .5 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	41167-0979	41167-0979-0	D	Discontinued by firm		2026-09-14

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41167-0979	41167-0979-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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: ACT Restoring Anticavity Fluoride Mint Burst
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.5 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
240698	Internal RxNorm lookup
656809	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
a38363e6-7105-4663-95a0-09ecb2948f83	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	SPL version
41167-0979-0	ACT Restoring Anticavity Fluoride Mint Burst	532 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	532	8
41167-0979-1	ACT Restoring Anticavity Fluoride Mint Burst	30 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	30	8
41167-0979-3	ACT Restoring Anticavity Fluoride Mint Burst	88 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	88	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0979	ACT RESTORING ANTICAVITY FLUORIDE MINT BURST (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20250214_a38363e6-7105-4663-95a0-09ecb2948f83.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 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT	SODIUM FLUORIDE	Colgate-Palmolive Company	b1ef8277-9919-453c-9d21-da4666d952de	2026-09-17	Warnings	Exact identifier application number: M021
TheraBreath	SODIUM FLUORIDE	Church & Dwight Co., Inc.	53c1086d-264b-9d00-e063-6394a90ad19d	2026-09-09	Warnings	Exact identifier application number: M021
Opalescence Whitening Cool Mint	SODIUM FLUORIDE	Ultradent Products, Inc.	44e7d0ed-3c37-5889-e063-6294a90afcca	2026-09-09	Warnings	Exact identifier application number: M021
Opalescence Whitening	SODIUM FLUORIDE	Ultradent Products, Inc	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	2026-09-09	Warnings	Exact identifier application number: M021
Opal by Opalescence Original	SODIUM FLUORIDE	Ultradent Products, Inc.	5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	2026-09-09	Warnings	Exact identifier application number: M021
Opal by Opalescence Complete	OPAL BY OPALESCENCE COMPLETE	Ultradent Products, Inc.	249cc46a-dad6-0345-e063-6394a90a4447	2026-09-09	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	Colgate-Palmolive Company	0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9	2026-09-09	Warnings	Exact identifier application number: M021
Colgate MaxFresh Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	de3674f4-3ce6-47d5-8391-6ad6789d68d9	2026-09-09	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity	SODIUM FLUORIDE	New World Imports, Inc	ef108fff-a79c-4e8d-8bf0-3fe567f93eb8	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity	SODIUM FLUORIDE	New World Imports, Inc	1a42cf2d-6c48-4e38-97bc-b6f2084bf39b	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Premium Anticavity Gel	SODIUM FLUORIDE	New World Imports, Inc	dfe564c1-2097-431d-93f0-cf423f254248	2026-09-08	Warnings	Exact identifier application number: M021
Freshmint Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	New World Imports, Inc	5aff7e41-58cd-5ab8-e063-6294a90aa1c7	2026-09-08	Warnings	Exact identifier application number: M021
Colgate Optic White Advanced Sparkling White	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	bc56603d-4190-48c1-b16e-3179a650cb39	2026-09-06	Warnings	Exact identifier application number: M021
Dentalclean Advanced Pro	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	4d261dc8-b065-567f-e063-6294a90aa93f	2026-09-04	Warnings	Exact identifier application number: M021
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
Unpaste	ZERO WASTE FLUORIDE MINT TOOTH TABS	Avespan LLC	312ae88d-7ea4-b3e0-e063-6294a90a99e5	2026-09-01	Warnings	Exact identifier application number: M021
Dentalclean Regenerator Sensitive Dental Gel with Fluoride	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	176aa3ed-e2a4-536d-e063-6294a90aa097	2026-08-31	Warnings	Exact identifier application number: M021
Listerine Total Care Fresh Mint Anticavity	SODIUM FLUORIDE	Kenvue Brands LLC	b2ce66c3-dc48-47a5-a731-5550bc194679	2026-08-28	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Your Military Exchanges	cef74e9c-d3b5-4e92-9908-187be97b63ab	2026-08-28	Warnings, Adverse reactions	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
656809	ACT 0.05 % (fluoride ion 0.02 % ) Mouthwash	PSN	a38363e6-7105-4663-95a0-09ecb2948f83	8
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	a38363e6-7105-4663-95a0-09ecb2948f83	8
656809	sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]	SBD	a38363e6-7105-4663-95a0-09ecb2948f83	8
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	a38363e6-7105-4663-95a0-09ecb2948f83	8
656809	ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) Mouthwash	SY	a38363e6-7105-4663-95a0-09ecb2948f83	8
656809	ACT Fluoride Rinse 0.5 MG/ML Mouthwash	SY	a38363e6-7105-4663-95a0-09ecb2948f83	8
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	a38363e6-7105-4663-95a0-09ecb2948f83	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-0979-0	41167097900	532 mL in 1 BOTTLE, PLASTIC (41167-0979-0)	532 ml	2015-12-16	0000-00-00	No	No	Current
41167-0979-1	41167097901	30 mL in 1 BOTTLE, PLASTIC (41167-0979-1)	30 ml	2015-12-16	0000-00-00	No	No	Current
41167-0979-3	41167097903	88 mL in 1 BOTTLE, PLASTIC (41167-0979-3)	88 ml	2015-12-16	0000-00-00	No	No	Current