FDA.reportPublic FDA data

Toothache - Guchutang Biotechnology (Longyan) Co., Ltd

Manufacturer
Guchutang Biotechnology (Longyan) Co., Ltd
Effective date
2026-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:34:45

Label at a glance#

ProductToothache
Active ingredientPOLIHEXANIDE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Activeingredient....
.Purpose
Polyhexamethylene Biguanide Hydrochloride 0.25%
Antibacterial

OTC - PURPOSE SECTION

Topical care for dental sufferers; relieves halitosis, periodontal & gum discomfort,
aids gum repair &conditioning.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keepoutofreachof children
if swallowed, get medical help or contacta Poison Control Center right away,

WARNINGS SECTION

1. This product isnot food, medicine or medical device. Do nottake orally. Keep out
2. If local irritation or discomfort occurs while using this product, please consult a
3. This is a health care product and cannot replace medicines or medical devices for treating diseases.

DOSAGE & ADMINISTRATION SECTION

Spray directlyon the mouth (toothache) for discomfort, 1-3 sprays each time, 2-3
times a day or as needed.

INACTIVE INGREDIENT SECTION

Watermelon Frost, Honeysuckde Extract,
Propolis Extract, Dandelion Extract, Gleditsia
Sinensis Thorn Extract, Honeysuckle Stem
Extract, Glycerol (Glycerin), xylitol, Food
Grade Flavor Essence, Ammonium Chloride,
Purified Water,

INDICATIONS & USAGE SECTION

if you are pregnant, breastfeeding, an infant or young child, or if you have an allergy
to any ingredientof this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87083-01287083-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
AMMONIUM CHLORIDE01Q9PC255DIACT
WATER059QF0KO0RIACT
PROPOLIS CERA6Y8XYV2NOFIACT
XYLITOLVCQ006KQ1EIACT
GLEDITSIA SINENSIS THORN26LKE578NYIACT
CITRULLUS LANATUS WHOLE3J5I6254YOIACT
POLIHEXANIDE HYDROCHLORIDE4XI6112496ACTIB
TARAXACUM OFFICINALE ROOT9DE5YCO0RUIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
ndc (package): 87083-012-01
ndc (product): 87083-012
ndc11 (package): 87083001201
spl id: 54ad2ceb-2730-e5ba-e063-6394a90aec5f
spl set id: 54ad2ceb-272f-e5ba-e063-6394a90aec5f

Reported adverse events (FAERS/openFDA)#

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