Anticavity

Product NDC: 49035-163
11-digit product format: 490350163
Labeler code: 49035
Product ID: 49035-163_4bd46c09-9072-40c4-e063-6394a90a22a4
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Walmart Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-05-13
Substance: SODIUM FLUORIDE
Active strength: .1 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	49035-163		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	49035-163	49035-163-86	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
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
e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d	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
49035-163-86	Anticavity	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-163	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]	15	Current NDC, Legacy NDC, 1 package rows	20240730_e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d.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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Restore and Defend	STANNOUS FLUORIDE	Walgreens	e808ea4b-9081-085b-e053-2a95a90a4f9b	2026-06-02	Warnings	Exact identifier application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinse	SODIUM FLUORIDE	Colgate-Palmolive Company	a1014431-7d23-aaff-6dc7-ab58683d0338	2026-06-02	Warnings	Exact identifier application number: M021
Therabreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	feab3d45-ff95-4b32-8258-7d932a7380c9	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Toy Story 5 Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b80947d-f389-2f80-e063-6294a90abd55	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	54113245-0c1e-739e-e063-6294a90aea42	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	545258fd-8179-fffc-e063-6394a90a467f	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Paw Patrol	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d87bea-3e99-5d04-e053-2a95a90aaf54	2026-06-01	Warnings	Exact identifier application number: M021
Orajel SuperMario	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	27d2f6cb-8661-da9c-e063-6394a90a5bde	2026-06-01	Warnings	Exact identifier application number: M021
Orajel KidsToothpaste	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d62125-c2c5-5926-e053-2995a90aaa29	2026-06-01	Warnings	Exact identifier application number: M021
AIM CAVITY PROTECTION Multi Benefit	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0f8a33-0b01-40e2-e054-00144ff88e88	2026-06-01	Warnings	Exact identifier application number: M021
Crest plus Tartar Protection Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560980ea-749f-593d-e063-6394a90a1b9e	2026-06-01	Warnings	Exact identifier application number: M021
Colgate Revitalizing White	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	c67223ae-b068-41c5-a15b-7ae9840b93ef	2026-05-27	Warnings	Exact identifier application number: M021
Colgate Kids Harry Potter	SODIUM FLUORIDE	Colgate-Palmolive Company	61c06da4-9f02-4fbc-b80f-1c443e298496	2026-05-26	Warnings	Exact identifier application number: M021
sodium fluoride rinse	SODIUM FLUORIDE RINSE	Rockland Cosmetics, Inc.	52430b12-4d5f-d1e1-e063-6394a90abd64	2026-05-20	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	d0a52519-3339-40ea-93e5-78f76d348a4d	2026-05-14	Warnings, Adverse reactions	Exact identifier application number: M021
Burts Bees Extra White	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c92524fd-8b93-592d-e053-2a95a90a88c6	2026-05-13	Warnings	Exact identifier application number: M021
MIPaste Plus Strawberry	SODIUM FLUORIDE	GC America Inc.	1b68bd67-65d3-4c64-e054-00144ff8d46c	2026-05-12	Warnings	Exact identifier application number: M021
White Glo Purple Color Corrector Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	6f8b77c3-9833-4c75-b41c-a2bc12616157	2026-05-12	Warnings	Exact identifier application number: M021
botalab HERBAL COMPLETE TOOTH	SODIUM FLUORIDE	KMPHARMACEUTICAL CO., LTD.	51365ef7-ed94-2650-e063-6394a90ab89e	2026-05-07	Warnings	Exact identifier application number: M021
Morning Fresh Mint Toothpaste, with Fluoride	MORNING FRESH MINT TOOTHPASTE, WITH FLUORIDE	Dynarex Corporation	2a42d8ce-e7f2-caa5-e063-6294a90ac01f	2026-05-07	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	e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d	17
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d	17
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d	17
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-163-86	49035016386	1000 mL in 1 BOTTLE, PLASTIC (49035-163-86)	1000 ml	2006-05-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equate 163.005/163AG Anticavity Fluoride Rinse	Walmart Inc. \| Nice-Pak Products, LLC	2026-02-27	HUMAN OTC DRUG LABEL	17