FDA.reportPublic FDA data

Tinnitus patch

Manufacturer
ZHENGZHOU GIANT BIOCHEMISTRY GROUP CO.,LTD
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:25:46

Label at a glance#

ProductTinnitus patch
Active ingredientCYNOMORIUM SONGARICUM STEM
Label structure10 sections

Storage and handling

Sealed and stored in a dry and dark place with good ventilation and room temperature. [Shelf Life] 36 months

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

CYNOMORIUM SONGARICUM STEM

OTC - PURPOSE SECTION

Easy to Use，Relieve Insomnia
Suitable for All Kinds of Ear Problems
Highly Permeable Ear-ringing Deeper Relief Tinnitus
Solve tinnitus,auditory hallucinations and other hearing impairments

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children must use it under the supervision of adults

INDICATIONS & USAGE SECTION

lt has the health care function of nourishing gi and blood, nourishing liver and kidney; lt is suitable for the sub-healthy people who suffer from local discomfort caused by dizziness and tinnitus such as cicadas.

WARNINGS SECTION

1 . This product is for external use. lt is forbidden to take orally.
2. It is forbidden for pregnant women and those who are allergic to this product, and should be used with caution for those with allergic constitution.
3. lt is forbidden to paste on the skin with ulceration, damage and infection.
4. For foreign bodies in the external auditory canal, you should go to the hospital.
5. Children must use it under the supervision of adults.
6. This product is a health care product and cannot replace drugs and medical devices.

DOSAGE & ADMINISTRATION SECTION

Respectively clean the front and back of the ear skin, dry, open the packaging, remove the backing paper,paste paste on the skin, each stick 4 ~ 8 hours, once a day, 15 days for a cycle.

STORAGE AND HANDLING SECTION

Sealed and stored in a dry and dark place with good ventilation and room temperature.
[Shelf Life] 36 months

OTC - DO NOT USE SECTION

1 . This product is for external use. lt is forbidden to take orally.
2. It is forbidden for pregnant women and those who are allergic to this product, and should be used with caution for those with allergic constitution.

INACTIVE INGREDIENT SECTION

POLYGONATI RHIZOMA
HIPPOCAMPUS
CNIDII FRUCTUS
ASTRAGALI RADIX
CISTANCHES HERBA
TAMARICIS CACUMEN
GANODERMA
NOTOGINSENG RADIX ET RHIZOMA
CARTHAMI FLOS
DENDROBII CAULIS
CURCUMAE RHIZOMA
EUODIAE FRUCTUS
CYNANCHI PANICULATI RADLXET RHIZOMA
ACONITI LATERAKIS RADIX PRAEPARATA
GENTIANAE MACROPHYLLAE RADIX
ACANTHOPANACIS CORTEX
LAUROCAPRAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52784-030-012025-07-29C16284748780-13b156c62-2e04-fb37-e063-e6dba90a4e07Tinnitus patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52784-030-01Tinnitus patch8 in 1 BAGPATCH81
52784-030-01Tinnitus patch4 in 1 BOXPATCH41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52784-030TINNITUS PATCH (CYNOMORII HERBA) PATCH [ZHENGZHOU GIANT BIOCHEMISTRY GROUP CO.,LTD]12 package rows20240123_0f487b86-c3a6-0b63-e063-6294a90a87fa.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52784-03052784-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CISTANCHE TUBULOSA STEM1GEP68JB91IACT
TETRADIUM RUTICARPUM FRUITQ413WWJ3X9IACT
DENDROBIUM NOBILE STEMCGO90PC910IACT
CYNOMORIUM SONGARICUM STEM8557NML9E6ACTIB
CNIDIUM MONNIERI FRUITV1IA3S3CUSIACT
REISHITKD8LH0X2ZIACT
TAMARIX CHINENSIS TOP5SQ6IOI13LIACT
SAFFLOWER4VBL71TY4YIACT
CURCUMA AROMATICA ROOTC7X957O5YSIACT
ASTRAGALUS MONGHOLICUS ROOT922OP8YUPFIACT
ACONITUM CARMICHAELII WHOLEQW81833K5YIACT
GENTIANA MACROPHYLLA ROOT6559FC0U1BIACT
LAUROCAPRAM1F3X9DRV9XIACT
ELEUTHEROCOCCUS NODIFLORUS ROOT BARKW7PRK433YBIACT
PANAX NOTOGINSENG ROOTGQX1C1175UIACT
CYNANCHUM PANICULATUM ROOTCZP7EPR012IACT
POLYGONATUM CYRTONEMA ROOTW93B56AH6RIACT
HIPPOCAMPUS HISTRIX540E19682DIACT

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
0f487b86-c3a7-0b63-e063-6294a90a87fa0f487b86-c3a6-0b63-e063-6294a90a87fa2024-01-19WarningsExact identifier
spl id: 0f487b86-c3a7-0b63-e063-6294a90a87fa
spl set id: 0f487b86-c3a6-0b63-e063-6294a90a87fa

Reported adverse events (FAERS/openFDA)#

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