SMART SENSE

Product NDC: 49738-552
11-digit product format: 497380552
Labeler code: 49738
Product ID: 49738-552_1c7cb46c-2865-4290-adc4-5a5df3f104c1
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: KMART CORPORATION
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-05-09
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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	49738-552		I	Inactivated by FDA		2026-10-15
excluded package	package	49738-552	49738-552-34	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 · 42 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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`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	49738-552-34	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
49738-552-34	2020-01-31	C162847	48780-1	9d75b9d0-9475-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49738-552-34	SMART SENSEANTICAVITY	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000		1

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49738-552	SMART SENSE ANTICAVITY (SODIUM FLUORIDE) LIQUID [KMART CORPORATION]	1	Legacy NDC, 1 package rows	20130528_cf6019ae-3b87-4f36-a5a0-05a2a45ed799.zip

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	cf6019ae-3b87-4f36-a5a0-05a2a45ed799	1
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	cf6019ae-3b87-4f36-a5a0-05a2a45ed799	1
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	cf6019ae-3b87-4f36-a5a0-05a2a45ed799	1
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	cf6019ae-3b87-4f36-a5a0-05a2a45ed799	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49738-552-34	49738055234	1000 mL in 1 BOTTLE, PLASTIC	1000 ml	Historical