Toothache

Product NDC: 87083-012
11-digit product format: 870830012
Labeler code: 87083
Product ID: 87083-012_54ad2ceb-2730-e5ba-e063-6394a90aec5f
Type: HUMAN OTC DRUG
Nonproprietary name: Polyhexamethylene Biguanide Hydrochloride
Dosage form: SPRAY
Route: TOPICAL
Labeler: Guchutang Biotechnology (Longyan) Co., Ltd
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-06-20
Substance: POLIHEXANIDE HYDROCHLORIDE
Active strength: .25 g/100mL
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: Toothache
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLIHEXANIDE HYDROCHLORIDE	.25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4XI6112496	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
54ad2ceb-272f-e5ba-e063-6394a90aec5f	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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4XI6112496	POLIHEXANIDE HYDROCHLORIDE	32289-58-0	POLIHEXANIDE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87083-012-01	87083001201	30 mL in 1 BOTTLE (87083-012-01)	30 ml	2026-06-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Toothache - Guchutang Biotechnology (Longyan) Co., Ltd	Guchutang Biotechnology (Longyan) Co., Ltd	2026-06-20	HUMAN OTC DRUG LABEL	1