ACT Restoring Anticavity Fluoride Mint Burst

Product NDC: 41167-0978
11-digit product format: 411670978
Labeler code: 41167
Product ID: 41167-0978_d930bfa0-e3cb-459a-a6c9-e99ac02ece1d
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: .2 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	.2 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	8ZYQ1474W7
Rxcui	313029, 1044540

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41167-0978-1	ACT Restoring Anticavity Fluoride Mint Burst	30 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	30		8
41167-0978-3	ACT Restoring Anticavity Fluoride Mint Burst	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		8
41167-0978-6	ACT Restoring Anticavity Fluoride Mint Burst	1250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1250		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0978	ACT RESTORING ANTICAVITY FLUORIDE MINT BURST (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20241004_0c7ede82-3b28-40ae-8dfd-cec58825f938.zip

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	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
1044540	sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]	SBD	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
1044540	ACT Braces Care 0.02 % Mouthwash	SY	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
1044540	ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) Mouthwash	SY	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
1044540	ACT Fluoride Rinse 0.2 MG/ML Mouthwash	SY	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	0c7ede82-3b28-40ae-8dfd-cec58825f938	8
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	0c7ede82-3b28-40ae-8dfd-cec58825f938	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-0978-1	41167097801	30 mL in 1 BOTTLE, PLASTIC (41167-0978-1)	30 ml	2016-02-22	0000-00-00	No	No	Current
41167-0978-3	41167097803	1000 mL in 1 BOTTLE, PLASTIC (41167-0978-3)	1000 ml	2015-12-16	0000-00-00	No	No	Current
41167-0978-6	41167097806	1250 mL in 1 BOTTLE, PLASTIC	1250 ml					Historical