FDA.reportPublic FDA data

Comfort Down There

Product NDC
76472-7009
Requested package NDC
76472-7009-2
11-digit product format
764727009
Labeler code
76472
Product ID
76472-7009_594f5100-8657-45a9-e063-6394a90a3ce5
Type
HUMAN OTC DRUG
Nonproprietary name
Aesculus hippocastanum 5C, Aloe 5C, Berberis vulgaris 3C, Capsicum Annuum 5C, Carduus marianus 3C, Nux vomica 5C, Pulsatilla 9C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
CAPSICUM ANNUUM WHOLE; STRYCHNOS NUX-VOMICA SEED; ALOE FEROX WHOLE; AESCULUS HIPPOCASTANUM WHOLE; BERBERIS VULGARIS ROOT BARK; PULSATILLA VULGARIS WHOLE; SILYBUM MARIANUM SEED
Active strength
.1; .1; .1; .1; .1; .1; .1 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Comfort Down There
Brand name suffix
Hemorrhoids
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSICUM ANNUUM WHOLE.1 mg/100mL
STRYCHNOS NUX-VOMICA SEED.1 mg/100mL
ALOE FEROX WHOLE.1 mg/100mL
AESCULUS HIPPOCASTANUM WHOLE.1 mg/100mL
BERBERIS VULGARIS ROOT BARK.1 mg/100mL
PULSATILLA VULGARIS WHOLE.1 mg/100mL
SILYBUM MARIANUM SEED.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7FKZ3QQQ1FInternal UNII lookup
269XH13919Internal UNII lookup
R0RP86FLN8Internal UNII lookup
2331W47PSXInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
I76KB35JEVInternal UNII lookup
U946SH95EEInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55001764-8bc9-cbac-e063-6394a90a455cAvailable on FDA.report

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
Comfort Down There HemorrhoidsAESCULUS HIPPOCASTANUM 5C, ALOE 5C, BERBERIS VULGARIS 3C, CAPSICUM ANNUUM 5C, CARDUUS MARIANUS 3C, NUX VOMICA 5C, PULSATILLA 9CSEVENE USA55001764-8bc9-cbac-e063-6394a90a455c2026-08-18WarningsExact identifier
ndc (package): 76472-7009-2
ndc (product): 76472-7009
ndc11 (package): 76472700902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7009-2764727009021 BOTTLE, SPRAY in 1 BOX (76472-7009-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7009-1) 2026-08-19NoNoCurrent