Anticavity

Product NDC: 41250-163
11-digit product format: 412500163
Labeler code: 41250
Product ID: 41250-163_4b32244e-5b7a-60d5-e063-6394a90a8d6e
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Meijer, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-05-18
Substance: SODIUM FLUORIDE
Active strength: .2 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41250-163		I	Inactivated by FDA		2026-10-15
excluded package	package	41250-163	41250-163-08	I	Inactivated by FDA		2026-10-15

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41250-163-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41250-163-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41250-163-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41250-163-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41250-163-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41250-163-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41250-163-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41250-163-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41250-163-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	41250-163-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	41250-163-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41250-163-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	41250-163-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	41250-163-08	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	41250-163-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	41250-163-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	41250-163-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	41250-163-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	41250-163-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	41250-163-08	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	41250-163-08	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	41250-163-08	`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	.2 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
c628d02f-c834-42b3-b38d-6b9cdcdd0961	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41250-163-08	2019-11-13	C162847	48780-1	97449f38-bbeb-f6ea-e053-dbdaa90aa703	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41250-163-86	Anticavity	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		18
41250-163-08	ANTIBACTERIAL FOAMINGPEAR	221 mL in 1 BOTTLE, PUMP	LIQUID	221		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
AMMONIUM LAURYL SULFATE	INACTIVE INGREDIENT	Q7AO2R1M0B	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
C12-16 ALCOHOLS	INACTIVE INGREDIENT	S4827SZE3L	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
POLYQUATERNIUM-10 (400 CPS AT 2%)	INACTIVE INGREDIENT	HB1401PQFS	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
SODIUM XYLENESULFONATE	INACTIVE INGREDIENT	G4LZF950UR	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-163	ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [MEIJER DISTRIBUTION, INC]	16	Current NDC, Legacy NDC, 1 package rows	20240214_c628d02f-c834-42b3-b38d-6b9cdcdd0961.zip
41250-163	ANTIBACTERIAL FOAMING PEAR (TRICLOSAN) LIQUID [MEIJER DISTRIBUTION INC]	1	Current NDC, Legacy NDC, 1 package rows	20111118_e4763fc7-2719-41e6-9c0d-2108c086877f.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	c628d02f-c834-42b3-b38d-6b9cdcdd0961	18
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	c628d02f-c834-42b3-b38d-6b9cdcdd0961	18
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	c628d02f-c834-42b3-b38d-6b9cdcdd0961	18
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	c628d02f-c834-42b3-b38d-6b9cdcdd0961	18
1053855	triclosan 0.46 % Medicated Liquid Soap	PSN	e4763fc7-2719-41e6-9c0d-2108c086877f	1
1053855	triclosan 4.6 MG/ML Medicated Liquid Soap	SCD	e4763fc7-2719-41e6-9c0d-2108c086877f	1
1053855	triclosan 0.46 % Foaming Medicated Hand Soap	SY	e4763fc7-2719-41e6-9c0d-2108c086877f	1
1053855	triclosan 0.46 % Medicated Liquid Soap	SY	e4763fc7-2719-41e6-9c0d-2108c086877f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-163-08	41250016308	221 mL in 1 BOTTLE, PUMP	221 ml					Historical
41250-163-86	41250016386	1000 mL in 1 BOTTLE, PLASTIC (41250-163-86)	1000 ml	2009-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer 163.005/163AG Anticavity Fluoride Rinse	Meijer, Inc. \| Nice-Pak Products, LLC	2026-02-19	HUMAN OTC DRUG LABEL	18
DRUG FACTS	MEIJER DISTRIBUTION INC \| APOLLO HEALTH AND BEAUTY CARE	2011-11-16	HUMAN OTC DRUG LABEL	1