MedActive Patient Friendly

Product NDC: 49741-1007
11-digit product format: 497411007
Labeler code: 49741
Product ID: 49741-1007_d4646175-37dc-12f1-e053-2a95a90aab1c
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride
Dosage form: KIT
Route: ORAL
Labeler: Integrate Oral Care, LLC.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-07-31
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49741-1007		I	Inactivated by FDA	2026-10-05
excluded package	package	49741-1007	49741-1007-2	I	Inactivated by FDA	2026-10-05
excluded package	package	49741-1007	49741-1007-3	I	Inactivated by FDA	2026-10-05

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 · 45 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	49741-1007-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49741-1007-3	`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	49741-1007-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49741-1007-3	`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	49741-1007-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49741-1007-3	`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	49741-1007-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49741-1007-3	`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	49741-1007-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49741-1007-3	`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	49741-1007-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49741-1007-3	`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	49741-1007-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49741-1007-3	`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	49741-1007-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49741-1007-3	`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	49741-1007-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49741-1007-3	`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	49741-1007-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49741-1007-3	`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	49741-1007-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49741-1007-3	`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	49741-1007-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49741-1007-3	`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	49741-1007-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49741-1007-3	`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	49741-1007-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49741-1007-3	`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	49741-1007-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49741-1007-3	`1332a3947898…`	`d4bfe170f9cd…`

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49741-1007-2	2023-01-30	C162847	48780-1	f386c64a-1aff-0266-e053-dadaa90a7c1a	18cc93a4-0ddf-1fa9-e054-00144ff88e88
49741-1007-3	2023-01-30	C162847	48780-1	f386c64a-1aff-0266-e053-dadaa90a7c1a	18cc93a4-0ddf-1fa9-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49741-1007-1	MedActive Patient Friendly	1 in 1 CARTON	KIT	1	12
49741-1007-2	MedActive Patient Friendly	10 in 1 BOX	KIT	10	12
49741-1007-3	MedActive Patient Friendly	1 in 1 CARTON	KIT	1	12
49741-1007-3	MedActive Patient Friendly	30 in 1 BOX	KIT	30	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49741-1007	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [INTEGRATE ORAL CARE, LLC.]	12	Legacy NDC, 4 package rows	20211231_18cc93a4-0ddf-1fa9-e054-00144ff88e88.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	Stannous Fluoride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1654969	MedActive Oral Relief Rinse 0.1 % Oral Rinse	PSN	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
1654967	stannous fluoride 0.1 % Oral Rinse	PSN	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
583459	stannous fluoride 0.63 % Dental Solution	PSN	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
1654969	stannous fluoride 1 MG/ML Mouthwash [MedActive Rinse]	SBD	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
1654967	stannous fluoride 1 MG/ML Mouthwash	SCD	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
583459	stannous fluoride 6.3 MG/ML Mouthwash	SCD	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
1654969	MedActive Oral Relief Rinse 0.1 % Mouthwash	SY	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
1654969	MedActive Rinse 1 MG/ML Mouthwash	SY	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
583459	stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution	SY	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12
583459	stannous fluoride 0.63 % Dental Solution	SY	18cc93a4-0ddf-1fa9-e054-00144ff88e88	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49741-1007-1	49741100701	1 in 1 CARTON						Historical
49741-1007-2	49741100702	10 CARTON in 1 BOX (49741-1007-2) > 1 KIT in 1 CARTON (49741-1007-1) * 3.7 mL in 1 KIT * 27 mL in 1 KIT	10 carton	2014-07-31	0000-00-00	No	No	Current
49741-1007-3	49741100703	30 CARTON in 1 BOX (49741-1007-3) > 1 KIT in 1 CARTON * 3.7 mL in 1 KIT * 27 mL in 1 KIT	30 carton	2014-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MedActive Patient Friendly - Integrate Oral Care, LLC.	Integrate Oral Care, LLC.	2021-12-30	HUMAN OTC DRUG LABEL	12