FDA.reportPublic FDA data

SINUSIN Oral Drops

Manufacturer
Heel Inc
Effective date
2011-11-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:30

Label at a glance#

ProductSinusin
Active ingredientPULSATILLA VULGARIS, EUPHORBIA RESINIFERA RESIN, LUFFA OPERCULATA FRUIT, MERCURIC IODIDE, SILVER NITRATE, CALCIUM SULFIDE, SINUSITISINUM, INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED), INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED), INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)
Label structure8 sections

Indications and uses

For the temporary relief of: Nasal Congestion Rhinitis and Sinusitis Cold and Flu Nasal Symptoms

Dosage and administration

Adults and Children above 11 years: 10 drops orally 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For the temporary relief of:
  • Nasal Congestion
  • Rhinitis and Sinusitis
  • Cold and Flu Nasal Symptoms

WARNINGS

WARNINGS SECTION

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and Children above 11 years: 10 drops orally 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Each 50ml contains: Pulsatilla 2X, Euphorbium officinarum 6X, Luffa operculata 6X, Mercurius iodatus ruber 6X, Influenzinum 8X, Argentum nitricum 10X, Hepar sulphuris calcareum 10X, Sinusitisinum 13X 0.5 ml each.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Ethanol, Purified Water USP

PURPOSE

OTC - PURPOSE SECTION

Nasal Congestion, Rhinitis and Sinusitis, Cold and Flu Nasal Symptoms

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sinusin Oral Drop.jpg
Sinusin Oral Drop.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50114-3250-42019-11-13C16284748780-197449f38-c09e-f6ea-e053-dbdaa90aa703SINUSIN Oral Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50114-3250-4Sinusin50 mL in 1 BOTTLELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50114-3250SINUSIN (PULSATILLA VULGARIS AND EUPHORBIA RESINIFERA RESIN AND LUFFA OPERCULATA FRUIT AND MERCURIC IODIDE AND SILVER NITRATE AND CALCIUM SULFIDE AND SINUSITISINUM AND INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) AND INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) AND INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)) LIQUID [HEEL INC]1Legacy NDC, 1 package rows20120110_ffc639db-ba39-49ef-97c6-df2cb1a86ed4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q1
EUPHORBIA RESINIFERA RESINACTIVE INGREDIENT1TI1O9028K1
INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)ACTIVE INGREDIENT0835GZ42BC1
INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)ACTIVE INGREDIENTDRA5YV248Q1
INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)ACTIVE INGREDIENT790PSW84271
LUFFA OPERCULATA FRUITACTIVE INGREDIENTC4MO6809HU1
MERCURIC IODIDEACTIVE INGREDIENTR03O05RB0P1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZE1
SINUSITISINUMACTIVE INGREDIENTB575563DM51
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
EUPHORBIA RESINIFERA RESINACTIVE MOIETY1TI1O9028K1
INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)ACTIVE MOIETY0835GZ42BC1
INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)ACTIVE MOIETYDRA5YV248Q1
INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)ACTIVE MOIETY790PSW84271
LUFFA OPERCULATA FRUITACTIVE MOIETYC4MO6809HU1
MERCURIC IODIDEACTIVE MOIETYR03O05RB0P1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SILVER CATIONACTIVE MOIETY57N7B0K90A1
SINUSITISINUMACTIVE MOIETYB575563DM51
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50114-325050114-3250-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PULSATILLA VULGARISI76KB35JEVACTIB
EUPHORBIA RESINIFERA RESIN1TI1O9028KACTIB
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
MERCURIC IODIDER03O05RB0PACTIB
SILVER NITRATE95IT3W8JZEACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
SINUSITISINUMB575563DM5ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)DRA5YV248QACTIB
INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)0835GZ42BCACTIB
INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)790PSW8427ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates

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
d13fa4ba-b63a-41ef-aaae-7636eeba7e8dffc639db-ba39-49ef-97c6-df2cb1a86ed42011-11-14WarningsExact identifier
spl id: d13fa4ba-b63a-41ef-aaae-7636eeba7e8d
spl set id: ffc639db-ba39-49ef-97c6-df2cb1a86ed4

Reported adverse events (FAERS/openFDA)#

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