ACT Whitening Anticavity Gentle Mint

Product NDC: 41167-0983
11-digit product format: 411670983
Labeler code: 41167
Product ID: 41167-0983_e0e0a4a0-368c-4b6c-94bb-0988f3d8cc58
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride 0.02 (0.009 w/v fluoride ion)
Dosage form: MOUTHWASH
Route: TOPICAL
Labeler: Chattem, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-01
Substance: SODIUM FLUORIDE
Active strength: .09 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 Whitening Anticavity Gentle Mint
Listing expiration: 2027-12-31

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
cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	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
41167-0983-2	ACT Whitening Anticavity Gentle Mint	500 mL in 1 BOTTLE	MOUTHWASH	500		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0983	ACT WHITENING ANTICAVITY GENTLE MINT (SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)) MOUTHWASH [CHATTEM, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240906_cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49.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 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec	2025-12-05	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	8b28b857-9162-4065-b0a0-571efffe9787	2025-12-05	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Ortho	SODIUM FLUORIDE	Dr Jen Natural, LLC	9dd248bf-9488-43cd-a041-e8315a05ce5d	2025-12-04	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Perio	SODIUM FLUORIDE	Dr Jen Natural, LLC	8c7e6d3a-49d9-4098-9d5e-e9792b373574	2025-12-04	Warnings	Exact identifier application number: M021
Colgate Total Plaque Cleanse	STANNOUS FLUORIDE	Colgate-Palmolive Company	b2980238-5bcb-467f-9e90-a307938632c2	2025-12-03	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	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
1044540	sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]	SBD	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
1044540	ACT Braces Care 0.02 % Mouthwash	SY	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
1044540	ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) Mouthwash	SY	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
1044540	ACT Fluoride Rinse 0.2 MG/ML Mouthwash	SY	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-0983-2	41167098302	500 mL in 1 BOTTLE (41167-0983-2)	500 ml	2019-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACT Whitening Anticavity Fluoride Mouthwash Gentle Mint	Chattem, Inc.	2026-01-12	HUMAN OTC DRUG LABEL	5