FDA.reportPublic FDA data

ColdCalm

Product NDC
0220-9287
11-digit product format
002209287
Labeler code
0220
Product ID
0220-9287_4ae2f15e-45f4-e2e4-e063-6294a90a92bc
Type
HUMAN OTC DRUG
Nonproprietary name
ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLE
Dosage form
TABLET
Route
ORAL
Labeler
Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-02-15
Substance
APIS MELLIFERA; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED
Active strength
6; 6; 3; 6; 3; 6; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ColdCalm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PULSATILLA VULGARIS6 [hp_C]/1
ONION6 [hp_C]/1
PHYTOLACCA AMERICANA ROOT3 [hp_C]/1
GELSEMIUM SEMPERVIRENS ROOT6 [hp_C]/1
EUPATORIUM PERFOLIATUM FLOWERING TOP3 [hp_C]/1
POTASSIUM DICHROMATE6 [hp_C]/1
ATROPA BELLADONNA6 [hp_C]/1
APIS MELLIFERA6 [hp_C]/1
STRYCHNOS NUX-VOMICA SEED3 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I76KB35JEVInternal UNII lookup
492225Q21HInternal UNII lookup
11E6VI8VEGInternal UNII lookup
639KR60Q1QInternal UNII lookup
1W0775VX6EInternal UNII lookup
T4423S18FMInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
7S82P3R43ZInternal UNII lookup
269XH13919Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ae2f15e-45f3-e2e4-e063-6294a90a92bcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9287-04ColdCalm20 in 1 BLISTER PACKTABLET201
0220-9287-04ColdCalm3 in 1 CARTONTABLET31

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
ColdCalmONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae2f15e-45f3-e2e4-e063-6294a90a92bc2026-02-15WarningsExact identifier
ndc (product): 0220-9287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0220-9287-04002209287043 BLISTER PACK in 1 CARTON (0220-9287-04) / 20 TABLET in 1 BLISTER PACK3 blister pack2026-02-15NoNoCurrent