FDA.reportPublic FDA data

Sinus Tone

Manufacturer
Energetix Corp | OHM PHARMA INC.
Effective date
2017-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:08:29

Label at a glance#

ProductSinus Tone
Active ingredientONION, ECHINACEA ANGUSTIFOLIA, GOLDENSEAL, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, MERCURIC SULFIDE, SUS SCROFA NASAL MUCOSA, SODIUM SULFATE, NUTMEG, PULSATILLA VULGARIS
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (per drop)

Allium cepa 12X, Echinacea 4X, Hydrastis canadensis 5X, Kali bichromicum 12X, Mercurius solubilis 30X, Mercurius sulphuratus ruber 12X, Mucosa nasalis suis 9X, 12X, 6C, Natrum sulphuricum 12X, Nux moschata 6X, Pulsatilla 12X.

Purpose

Temporary relief of sinus congestion, sinus pain, hay fever.

INDICATIONS & USAGE SECTION

Uses

Temporary relief of sinus congestion, sinus pain, hay fever.

WARNINGS SECTION

Warnings

  • In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast feeding, ask a healthcare professional before use.
  • Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Take 30 drops orally twice daily or as directed by a healthcare professional.
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.

OTHER SAFETY INFORMATION

Other information

  • Store at room temperature out of direct sunlight.
  • Do not use if neck wrap is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Ethyl Alcohol, Glycerin, Purified Water.

OTC - QUESTIONS SECTION

Distributed by

Energetix Corp.

Dahlonega, GA 30533

Questions? Comments?

800.990.7085

www.goenergetix.com

OTC - PURPOSE SECTION

Sinus congestion, sinus pain, hay fever.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

energetix

Sinus-Tone

Homeopathic Remedy

Sinus congestion, sinus pain, hay fever.

2 fl oz (59.1 mL) / 15% Ethyl Alcohol

2 oz bottle label2 oz bottle label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64578-0129-12020-01-31C16284748780-19d75b9d1-1209-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64578-0129-1Sinus Tone59.1 mL in 1 BOTTLE, DROPPERLIQUID59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64578-0129SINUS TONE (ALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, KALI BICHROMICUM, MERCURIUS SOLUBILIS, MERCURIUS SULPHURATUS RUBER, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, NUX MOSCHATA, PULSATILLA (VULGARIS)) LIQUID [ENERGETIX CORP]2Legacy NDC, 1 package rows20170104_b707b05d-77dd-4a5a-ad9e-ce8320efa4f4.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64578-012964578-0129-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
MERCURIC SULFIDEZI0T668SF1ACTIB
SUS SCROFA NASAL MUCOSAID3Z1X61WYACTIB
SODIUM SULFATE0YPR65R21JACTIB
NUTMEGAEE24M3MQ9ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT

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
280b6d4a-f810-4213-889b-2b04be82f1d9b707b05d-77dd-4a5a-ad9e-ce8320efa4f42017-01-03WarningsExact identifier
spl id: 280b6d4a-f810-4213-889b-2b04be82f1d9
spl set id: b707b05d-77dd-4a5a-ad9e-ce8320efa4f4

Reported adverse events (FAERS/openFDA)#

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