Dental system starter kit

Product NDC: 87649-0001
11-digit product format: 876490001
Labeler code: 87649
Product ID: 87649-0001_55747c80-079a-f753-e063-6394a90aa296
Type: HUMAN OTC DRUG
Nonproprietary name: US convenience kit (718907)
Dosage form: KIT
Route: ORAL
Labeler: Dyson Technology Limited
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-06-10
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Dental system starter kit
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313029	Internal RxNorm lookup
1038800	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
5355b79b-711f-1a4a-e063-6394a90afc4b	Available on FDA.report

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 26 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	69271b7a-18c0-4445-8164-cb1620fb5475	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	40bd7406-7ee6-47fe-8481-0a4c8cefce65	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	43194fe1-87a1-4ffa-ad73-a1dcec91fd63	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	b0b3ab27-704a-44b8-8473-d21ac3359ba1	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	39f64f10-f442-45a9-a060-9f99e78c678d	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	ed5a294a-fc03-43dd-825d-23a232060900	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	be558e5b-cf35-4035-a69c-8d66deeac6b2	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	a2591a96-ed66-45b1-abf6-6b26d0bb4f44	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	efe92e48-5086-4b61-a298-0d8ceefe100e	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	1d6a1182-ab63-460a-ab91-8d4c2ae5d01e	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	e1db79a4-4a24-4c3f-9ee9-2af3f876ac96	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	d3b6669e-479f-4bc1-b533-5e9a0cc65213	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	e42a22ef-1035-4dd0-94b0-43625542d584	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	3dca05de-cf63-4ca0-88be-473ea637e6b4	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	c6eda1de-4490-4a28-8a31-cbf3e102e74e	2025-01-09	Warnings	Exact identifier application number: M022
Comfortcaine Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	4261cd90-5087-44a3-bef9-72d33dbf0dfd	2025-01-09	Warnings	Exact identifier application number: M022
Comfortcaine Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	e70240a8-fa9d-4005-a3a0-5cca6188bf61	2025-01-09	Warnings	Exact identifier application number: M022
Comfortcaine Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	fda3d254-e103-4be9-9086-51ad022b2b3f	2025-01-09	Warnings	Exact identifier application number: M022
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	c161da79-9ea5-4c7f-890c-4315129fe5bf	2025-01-08	Warnings	Exact identifier application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87649-0001-1	87649000101	1 BOTTLE in 1 BOX (87649-0001-1) / 1 TUBE in 1 BOTTLE / 1 KIT in 1 TUBE * 1 BOTTLE in 1 BOX / 400 mL in 1 BOTTLE * 1 TUBE in 1 BOX / 94.5 g in 1 TUBE	1 bottle	2026-06-10	No	No	Current