Coldcalm

Product NDC
0220-9048
11-digit product format
002209048
Labeler code
0220
Product ID
0220-9048_31bbb16b-e155-90c4-e063-6394a90af542
Type
HUMAN OTC DRUG
Nonproprietary name
ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION
Dosage form
TABLET
Route
ORAL
Labeler
Laboratoires Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1995-01-01
Substance
APIS MELLIFERA; ATROPA BELLADONNA; DICHROMATE ION; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED
Active strength
6; 6; 6; 3; 6; 3; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Coldcalm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA6 [hp_C]/1
ATROPA BELLADONNA6 [hp_C]/1
DICHROMATE ION6 [hp_C]/1
EUPATORIUM PERFOLIATUM FLOWERING TOP3 [hp_C]/1
GELSEMIUM SEMPERVIRENS ROOT6 [hp_C]/1
ONION3 [hp_C]/1
PHYTOLACCA AMERICANA ROOT6 [hp_C]/1
PULSATILLA VULGARIS6 [hp_C]/1
STRYCHNOS NUX-VOMICA SEED3 [hp_C]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, WQZ3G9PF0H, 9LKY4BFN2V, 1W0775VX6E, 639KR60Q1Q, 492225Q21H, 11E6VI8VEG, I76KB35JEV, 269XH13919

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9048-042020-02-25C16284748780-19d75b9d1-1d8e-f424-e053-dadaa90a57ceColdcalm
0220-9048-042020-01-31C16284748780-19d75b9d1-1d8e-f424-e053-dadaa90a57ceColdcalm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9048-04Coldcalm60 in 1 BLISTER PACKTABLET6014
0220-9048-29Coldcalm120 in 1 BLISTER PACKTABLET12014
0220-9048-91Coldcalm20 in 1 BLISTER PACKTABLET2014
0220-9048-92Coldcalm100 in 1 BLISTER PACKTABLET10014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43ZCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
DICHROMATE IONACTIVE INGREDIENT9LKY4BFN2VCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6ECOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
ONIONACTIVE INGREDIENT492225Q21HCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEGCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919COLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
APIS MELLIFERAACTIVE MOIETY7S82P3R43ZCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
DICHROMATE IONACTIVE MOIETY9LKY4BFN2VCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6ECOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
ONIONACTIVE MOIETY492225Q21HCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEGCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919COLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
LactoseINACTIVE INGREDIENTJ2B2A4N98GCOLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9048COLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION) TABLET [LABORATOIRES BOIRON]14Current NDC, Legacy NDC, 4 package rows20250406_af4a4765-8255-44fb-821c-4345a2a45e2a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9048-040022090480460 TABLET in 1 BLISTER PACK (0220-9048-04) 60 tablet1995-01-010000-00-00NoNoCurrent
0220-9048-2900220904829120 TABLET in 1 BLISTER PACK (0220-9048-29) 120 tablet2020-12-090000-00-00NoNoCurrent
0220-9048-910022090489120 TABLET in 1 BLISTER PACK (0220-9048-91) 20 tablet2021-07-140000-00-00NoNoCurrent
0220-9048-9200220904892100 TABLET in 1 BLISTER PACK (0220-9048-92) 100 tablet2025-04-01NoNoCurrent