FDA.reportPublic FDA data

Winter Relief

Product NDC
76472-7004
Requested package NDC
76472-7004-2
11-digit product format
764727004
Labeler code
76472
Product ID
76472-7004_594f58a2-2daf-494c-e063-6394a90abf2f
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus 9C, Arnica montana 9C, Belladonna 9C, Bryonia 9C, Dulcamara 9C, Eucalyptus globulus 3C, Eupatorium perfoliatum 9C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
SOLANUM DULCAMARA STEM; BRYONIA CRETICA SUBSP. DIOICA ROOT; ATROPA BELLADONNA WHOLE; ARNICA MONTANA; ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP
Active strength
.1; .1; .1; .1; .1; .1; .1 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
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
Winter Relief
Brand name suffix
Flu and Fever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLANUM DULCAMARA STEM.1 mg/100mL
BRYONIA CRETICA SUBSP. DIOICA ROOT.1 mg/100mL
ATROPA BELLADONNA WHOLE.1 mg/100mL
ARNICA MONTANA.1 mg/100mL
ACONITUM NAPELLUS.1 mg/100mL
EUCALYPTUS GLOBULUS LEAF.1 mg/100mL
EUPATORIUM PERFOLIATUM FLOWERING TOP.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IR986LE7DFInternal UNII lookup
53UB5FH7CXInternal UNII lookup
DSV74G1P2JInternal UNII lookup
O80TY208ZWInternal UNII lookup
U0NQ8555JDInternal UNII lookup
S546YLW6E6Internal UNII lookup
1W0775VX6EInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54e9a77a-9142-3cd5-e063-6294a90a6b12Available 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
Winter Relief Flu and FeverACONITUM NAPELLUS 9C, ARNICA MONTANA 9C, BELLADONNA 9C, BRYONIA 9C, DULCAMARA 9C, EUCALYPTUS GLOBULUS 3C, EUPATORIUM PERFOLIATUM 9CSEVENE USA54e9a77a-9142-3cd5-e063-6294a90a6b122026-08-18WarningsExact identifier
ndc (package): 76472-7004-2
ndc (product): 76472-7004
ndc11 (package): 76472700402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7004-2764727004021 BOTTLE, SPRAY in 1 BOX (76472-7004-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7004-1) 2026-08-19NoNoCurrent