FDA.reportPublic FDA data

SAMBUCUS NIGRA

Manufacturer
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Effective date
2020-03-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:12:53

Label at a glance#

ProductSAMBUCUS NIGRA
Active ingredientSAMBUCUS NIGRA FLOWERING TOP
Label structure9 sections

Indications and uses

Croupy Cough

Storage and handling

Store in a cool dark place

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SAMBUCUS NIGRA HPUS 1X and higher

USES

OTC - PURPOSE SECTION

Croupy Cough

INDICATIONS

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

WARNINGS

WARNINGS SECTION

This product is to be used for self-limiting conditions

OTC - STOP USE SECTION

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OTC - DO NOT USE SECTION

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose

STORAGE

STORAGE AND HANDLING SECTION

Store in a cool dark place

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-0388-02022-01-28C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-12022-01-28C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-22022-01-28C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-32022-01-28C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-42022-01-28C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-52022-01-28C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-02020-03-26C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-12020-03-26C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-22020-03-26C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-32020-03-26C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-42020-03-26C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-52020-03-26C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-02020-01-31C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-12020-01-31C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-22020-01-31C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-32020-01-31C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-42020-01-31C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61
15631-0388-52020-01-31C16284748780-19d75b9d0-a75c-f424-e053-dadaa90a57cee7346f2c-ca00-4e69-af26-e07ee32b1d61

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0388-0SAMBUCUS NIGRA100 in 1 VIAL, SINGLE-DOSEPELLET1002
15631-0388-1SAMBUCUS NIGRA200 in 1 PACKAGEPELLET2002
15631-0388-2SAMBUCUS NIGRA400 in 1 PACKAGEPELLET4002
15631-0388-3SAMBUCUS NIGRA750 in 1 PACKAGEPELLET7502
15631-0388-4SAMBUCUS NIGRA2500 in 1 PACKAGEPELLET25002
15631-0388-5SAMBUCUS NIGRA12500 in 1 PACKAGEPELLET125002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0388SAMBUCUS NIGRA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2Legacy NDC, 6 package rows20200327_e7346f2c-ca00-4e69-af26-e07ee32b1d61.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18U1
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18U1
SUCROSEINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15631-038815631-0388-0, 15631-0388-1, 15631-0388-2, 15631-0388-3, 15631-0388-4, 15631-0388-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 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
f97bf689-5357-478d-8c3a-4b3457c6e221e7346f2c-ca00-4e69-af26-e07ee32b1d612015-10-31WarningsExact identifier
spl set id: e7346f2c-ca00-4e69-af26-e07ee32b1d61

Reported adverse events (FAERS/openFDA)#

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