FDA.reportPublic FDA data

Sinus Soothe

Manufacturer
Feelgood Health | W.Last
Effective date
2010-08-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:02:36

Label at a glance#

ProductSinus Soothe
Active ingredientPOTASSIUM DICHROMATE, PULSATILLA PATENS, CALCIUM SULFIDE, CEDAR LEAF OIL, SPIGELIA
Label structure11 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Relieves sinus congestion, pain and headache

INDICATIONS & USAGE SECTION

Indications: Homeopathic remedy to relieve the symptoms of sinusitis

DOSAGE & ADMINISTRATION SECTION

Dosage: Mix 10-15 drops in ¼ cup of water and sip slowly. Repeat every 2 hours until symptoms subside. May be used with ImmunityPlus™ for immune system support and AllergiClear™  to sustain normal histamine levels.

GENERAL PRECAUTIONS SECTION

Caution: Consult your doctor if symptoms persist or worsen. Keep this and all medications out of reach of children.

OTC - ACTIVE INGREDIENT SECTION

Ingredients: Each dose contains equal parts of Kali bich (6C) (HPUS), Pulsatilla (6C) (HPUS), Hepar sulph (6C) (HPUS), Thuja occ (12C) (HPUS), Spigelia anth (6C) (HPUS)

INACTIVE INGREDIENT SECTION

Citricidal extract (inactive ingredient).

PREGNANCY SECTION

If pregnant or breastfeeding, ask a health professional before use.

WARNINGS SECTION

Contains no animal products, gluten, artificial flavors, preservatives or colorants. Suitable for vegetarians and safe for all ages.

INFORMATION FOR PATIENTS SECTION

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of reach of children.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68647-206-102019-10-21C16284748780-1956f9ecf-ccb1-621f-e053-dbdaa90a74adSINUS SOOTHE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68647-206-10Sinus Soothe50000 mL in 1 BOTTLE, GLASSTINCTURE500002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68647-206SINUS SOOTHE (KALI BICH, PULSATILLA, HEPAR SULPH , THUJA OCC , SPIGELIA ANTH ) TINCTURE [FEELGOOD HEALTH]2Legacy NDC, 1 package rows20100923_0bdede95-606b-482c-a066-248716fea07d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q2
CEDAR LEAF OILACTIVE INGREDIENTBJ169U4NLG2
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FM2
PULSATILLA PATENSACTIVE INGREDIENT4M1169RWJD2
SPIGELIAACTIVE INGREDIENT467D26HS0B2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB2
CEDAR LEAF OILACTIVE MOIETYBJ169U4NLG2
POTASSIUM CATIONACTIVE MOIETY295O53K1522
PULSATILLA PATENSACTIVE MOIETY4M1169RWJD2
SPIGELIAACTIVE MOIETY467D26HS0B2
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y72
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68647-20668647-206-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM DICHROMATET4423S18FMACTIB
PULSATILLA PATENS4M1169RWJDACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
CEDAR LEAF OILBJ169U4NLGACTIB
SPIGELIA467D26HS0BACTIB
CITRUS PARADISI SEED12F08874Y7IACT
WATER059QF0KO0RIACT

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
e2311abe-7c79-44ee-b73e-1b4746c87a1d0bdede95-606b-482c-a066-248716fea07d2010-08-17WarningsExact identifier
spl id: e2311abe-7c79-44ee-b73e-1b4746c87a1d
spl set id: 0bdede95-606b-482c-a066-248716fea07d

Reported adverse events (FAERS/openFDA)#

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