Anticavity Fluoride Rinse

Product NDC: 37808-163
11-digit product format: 378080163
Labeler code: 37808
Product ID: 37808-163_500ee303-72f4-68d5-e063-6394a90ac6d4
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: MOUTHWASH
Route: ORAL
Labeler: H E B
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-09-29
Substance: SODIUM FLUORIDE
Active strength: .1 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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	37808-163	37808-163-77	D	Discontinued by firm		2026-10-20

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 · 2 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	37808-163	37808-163-77	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37808-163	37808-163-77	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: Anticavity Fluoride Rinse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.1 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313029	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
87327a36-a314-4daa-83b6-b4bd3e26bba2	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
37808-163-77	Anticavity Fluoride Rinse	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500		15
37808-163-86	Anticavity Fluoride Rinse	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
EUCALYPTOL	INACTIVE INGREDIENT	RV6J6604TK	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
THYMOL	INACTIVE INGREDIENT	3J50XA376E	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-163	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]	12	Current NDC, Legacy NDC, 2 package rows	20240922_87327a36-a314-4daa-83b6-b4bd3e26bba2.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 37 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cloveden 100 times higher concentrated	CETYLPYRIDINIUM CHLORIDE	Acuseplanet Inc	3c0e1862-293f-4d23-e063-6294a90a33e1	2025-08-10	Warnings	Exact identifier application number: M021
Ipana Wintergreen Fluoride	SODIUM MONOFLUOROPHOSPHATE	Maxill Inc.	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	2025-07-28	Warnings	Exact identifier application number: M021
Ipana Bucky Beaver Bubble Gum Childrens Fluoride	SODIUM MONOFLUOROPHOSPHATE	Maxill Inc	e7aa2a8d-7140-4718-bf69-917bb50d32c7	2025-07-28	Warnings	Exact identifier application number: M021
Dubai Chocolate Flavor	ANTICAVITY TOOTHPASTE	SuperMouth, LLC.	d1615a53-ecfc-49d1-b836-f7643b9d2660	2025-07-24	Warnings	Exact identifier application number: M021
ACT Restoring Anticavity Fluoride Mint Burst	SODIUM FLUORIDE	Chattem, Inc.	0c7ede82-3b28-40ae-8dfd-cec58825f938	2025-07-23	Warnings	Exact identifier application number: M021
Dubai Chocolate Fluoride Mouthwash	ANTICAVITY MOUTHWASH	SuperMouth, LLC.	ef81a983-64c1-4913-9235-25451f023852	2025-07-23	Warnings	Exact identifier application number: M021
ACT Restoring Anticavity Fluoride Cool Mint	SODIUM FLUORIDE	Chattem, Inc.	3409a749-4a1a-4950-8c21-364d1b977af7	2025-07-22	Warnings	Exact identifier application number: M021
Act Total Care Anticavity Fluoride Fresh Mint	SODIUM FLUORIDE	Chattem, Inc.	dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8	2025-07-22	Warnings	Exact identifier application number: M021
Brush Buddies Oral Rinse Sparkle Mint	SODIUM FLUORIDE	ASHTEL STUDIOS, INC	fe2c06fc-6497-4888-877f-1a88e02fad20	2025-07-15	Warnings	Exact identifier application number: M021
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE	SODIUM FLUORIDE	Ashtel Studios, Inc.	1620c7fa-2af6-4462-af5d-9e122942788a	2025-07-15	Warnings	Exact identifier application number: M021
Dentalclean Green Diamond Alcohol Free Mouthwash	SODIUM FLUORIDE 0.05%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	5653aa33-4f0e-46b2-9be0-6219143556ec	2025-07-14	Warnings	Exact identifier application number: M021
Colgate Total Gum Protect Fresh Mint	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	570e3bd6-eede-4270-9d78-055aeb2b8c17	2025-07-14	Warnings	Exact identifier application number: M021
OraPro Fluoride Anticavity	FLUORIDE TOOTHPASTE	Protegera, Inc.	93b0181c-e29f-42f4-80f5-366463b68f09	2025-07-10	Warnings	Exact identifier application number: M021
Enamur Fluoride AntiCavity Toothpast	FLUORIDE TOOTHPAST	Protegera, Inc	557ced45-f54e-43d8-aa13-46f75b79367c	2025-07-10	Warnings	Exact identifier application number: M021
Super Strawberry	STRAWBERRY TOOTHPASTE	SuperMouth, LLC.	a8c2b68d-d28b-41c0-a383-cc706b25aa1a	2025-07-05	Warnings	Exact identifier application number: M021
Super Mint	SUPER MINT TOOTHPASTE	SuperMouth, LLC.	be0915f3-36c4-4200-9d15-704cfbd632b4	2025-07-05	Warnings	Exact identifier application number: M021
Super Vanilla	VANILLA TOOTHPASTE	SuperMouth, LLC.	3ddfe20a-86f1-4566-bb77-82c9749411f6	2025-07-05	Warnings	Exact identifier application number: M021
Super Chocolate	CHOCOLATE TOOTHPASTE	SuperMouth, LLC.	48607622-7c5e-4ddc-8d83-707f26c0553f	2025-07-05	Warnings	Exact identifier application number: M021
Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT	SODIUM FLUORIDE	Ashtel Studios, Inc.	13dba3ce-88a8-490c-a906-cfd206d1d290	2025-07-01	Warnings	Exact identifier application number: M021
evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT	SODIUM FLUORIDE	Ashtel Studios, Inc.	baae4f4a-54ef-472a-9c94-31703435750b	2025-07-01	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
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	87327a36-a314-4daa-83b6-b4bd3e26bba2	15
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	87327a36-a314-4daa-83b6-b4bd3e26bba2	15
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	87327a36-a314-4daa-83b6-b4bd3e26bba2	15
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	87327a36-a314-4daa-83b6-b4bd3e26bba2	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-163-77	37808016377	500 mL in 1 BOTTLE, PLASTIC (37808-163-77)	500 ml	2010-09-29	0000-00-00	No	No	Current
37808-163-86	37808016386	1000 mL in 1 BOTTLE, PLASTIC (37808-163-86)	1000 ml	2010-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HEB 163.005/163AF-AG Anticavity Fluoride Rinse	H E B \| Nice-Pak Products, LLC	2026-04-22	HUMAN OTC DRUG LABEL	15