FDA.reportPublic FDA data

Cold Comfort

Product NDC
76472-7003
Requested package NDC
76472-7003-2
11-digit product format
764727003
Labeler code
76472
Product ID
76472-7003_594f5d57-799c-8ef0-e063-6294a90a1761
Type
HUMAN OTC DRUG
Nonproprietary name
Allium cepa 5C, Euphrasia officinalis 5C, Hydrastis canadensis 5C, Nux vomica 5C, Pulsatilla 5C, Rumex crispus 5C,Sabadilla 5C, Sambucus nigra 5C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
SAMBUCUS NIGRA FLOWERING TOP; ALLIUM CEPA WHOLE; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; RUMEX CRISPUS ROOT; PULSATILLA VULGARIS WHOLE; EUPHRASIA OFFICINALIS LEAF; HYDRASTIS CANADENSIS WHOLE
Active strength
.1; .1; .1; .1; .1; .1; .1; .1 mg/100mL; 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
Cold Comfort
Brand name suffix
Cold and Cough
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAMBUCUS NIGRA FLOWERING TOP.1 mg/100mL
ALLIUM CEPA WHOLE.1 mg/100mL
STRYCHNOS NUX-VOMICA SEED.1 mg/100mL
SCHOENOCAULON OFFICINALE SEED.1 mg/100mL
RUMEX CRISPUS ROOT.1 mg/100mL
PULSATILLA VULGARIS WHOLE.1 mg/100mL
EUPHRASIA OFFICINALIS LEAF.1 mg/100mL
HYDRASTIS CANADENSIS WHOLE.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CT03BSA18UInternal UNII lookup
8P2VLG2456Internal UNII lookup
269XH13919Internal UNII lookup
6NAF1689IOInternal UNII lookup
9N1RM2S62CInternal UNII lookup
I76KB35JEVInternal UNII lookup
L4W0HL3P0FInternal UNII lookup
R763EBH88TInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54e9282a-604d-4acd-e063-6394a90a59ffAvailable 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
Cold Comfort Cold and CoughALLIUM CEPA 5C, EUPHRASIA OFFICINALIS 5C, HYDRASTIS CANADENSIS 5C, NUX VOMICA 5C, PULSATILLA 5C, RUMEX CRISPUS 5C,SABADILLA 5C, SAMBUCUS NIGRA 5CSEVENE USA54e9282a-604d-4acd-e063-6394a90a59ff2026-08-18WarningsExact identifier
ndc (package): 76472-7003-2
ndc (product): 76472-7003
ndc11 (package): 76472700302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7003-2764727003021 BOTTLE, SPRAY in 1 BOX (76472-7003-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7003-1) 2026-08-19NoNoCurrent