Coldcalm

Manufacturer: Laboratoires Boiron | Boiron Inc. | Boiron
Effective date: 2025-04-01
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: full-release
Hydrated at: 2026-06-01 02:33:07

Label at a glance#

ProductColdcalm

Active ingredientONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, DICHROMATE ION, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS

Label structure13 sections

Contacts and useful links#

PhoneLabel contact1-800-264-7661

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each tablet)

Allium cepa 3C HPUS (0.28 mg)

Apis mellifica 6C HPUS (0.28 mg)

Belladonna 6C HPUS (0.28 mg) (contains less than 10 ^-14 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.28 mg)

Gelsemium sempervirens 6C HPUS (0.28 mg) (contains less than 10 ^-14gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.28 mg) (contains less than 10 ^-13 mg chromium)

Nux vomica 3C HPUS (0.28 mg) (contains less than 10 ^-8 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.28 mg)

Pulsatilla 6C HPUS (0.28 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Allium cepa 3C HPUS ... Relieves sneezing and runny nose

Apis mellifica 6C HPUS ... Relieves nasal congestion

Belladonna 6C HPUS ... Relieves colds with a sudden onset

Eupatorium perfoliatum 3C HPUS ... Relieves aches and pain associated with colds

Gelsemium sempervirens 6C HPUS ... Relieves headaches associated with colds

Kali bichromicum 6C HPUS ... Relieves nasal discharge

Nux vomica 3C HPUS .... Relieves sneezing fits

Phytolacca decandra 6C HPUS ... Relieves occasional minor sore throat associated with colds

Pulsatilla 6C HPUS ... Relieves colds with a loss of taste and smell

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves cold symptoms such as:

sneezing
runny nose
nasal congestion
occasional minor sore throat

WARNINGS SECTION

Do not use if you are allergic to Apis.

OTC - ASK DOCTOR SECTION

Ask a doctor before use

in children under 4 years of age
if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting

OTC - STOP USE SECTION

Stop use and ask a doctor if sore throat worsens or persists for more than 2 days

nasal congestion worsens or lasts more than 5 days in children under 12 years of age or 7 days in adults

new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets every 6 hours. Decrease frequency with improvement.
Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

SPL UNCLASSIFIED SECTION

do not use if glued carton end flaps are open or if the blister seal is broken
store below 86° F (30° C)

Contains 20 meltaway tablets unflavored

Contains 60 meltaway tablets unflavored

Contains 100 meltway tablets unflavored

Contains 120 meltaway tablets unflavored

No Known Drug Interactions

Phenylephrine-free

Non-Drowsy

Cold Relief*

Sneezing, Runny Nose, Minor Sore Throat*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, magnesium stearate

OTC - QUESTIONS SECTION

Questions or comments

ColdCalm.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

LABEL

label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0220-9048-04	2020-02-25	C162847	48780-1	9d75b9d1-1d8e-f424-e053-dadaa90a57ce	Coldcalm
0220-9048-04	2020-01-31	C162847	48780-1	9d75b9d1-1d8e-f424-e053-dadaa90a57ce	Coldcalm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0220-9048-04	Coldcalm	60 in 1 BLISTER PACK	TABLET	60	14
0220-9048-29	Coldcalm	120 in 1 BLISTER PACK	TABLET	120	14
0220-9048-91	Coldcalm	20 in 1 BLISTER PACK	TABLET	20	14
0220-9048-92	Coldcalm	100 in 1 BLISTER PACK	TABLET	100	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0220-9048	COLDCALM (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]	14	Current NDC, Legacy NDC, 4 package rows	20250406_af4a4765-8255-44fb-821c-4345a2a45e2a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
APIS MELLIFERA	ACTIVE INGREDIENT	7S82P3R43Z	5
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	5
DICHROMATE ION	ACTIVE INGREDIENT	9LKY4BFN2V	5
EUPATORIUM PERFOLIATUM FLOWERING TOP	ACTIVE INGREDIENT	1W0775VX6E	5
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE INGREDIENT	639KR60Q1Q	5
ONION	ACTIVE INGREDIENT	492225Q21H	5
PHYTOLACCA AMERICANA ROOT	ACTIVE INGREDIENT	11E6VI8VEG	5
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	5
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	5
APIS MELLIFERA	ACTIVE MOIETY	7S82P3R43Z	5
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	5
DICHROMATE ION	ACTIVE MOIETY	9LKY4BFN2V	5
EUPATORIUM PERFOLIATUM FLOWERING TOP	ACTIVE MOIETY	1W0775VX6E	5
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE MOIETY	639KR60Q1Q	5
ONION	ACTIVE MOIETY	492225Q21H	5
PHYTOLACCA AMERICANA ROOT	ACTIVE MOIETY	11E6VI8VEG	5
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	5
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	5
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Coldcalm
ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION
ONION
APIS MELLIFERA
ATROPA BELLADONNA
EUPATORIUM PERFOLIATUM FLOWERING TOP
GELSEMIUM SEMPERVIRENS ROOT
DICHROMATE ION
STRYCHNOS NUX-VOMICA SEED
PHYTOLACCA AMERICANA ROOT
PULSATILLA VULGARIS
CROSCARMELLOSE SODIUM
LACTOSE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0220-9048	0220-9048-04, 0220-9048-29, 0220-9048-91, 0220-9048-92

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ONION	492225Q21H	ACTIB
APIS MELLIFERA	7S82P3R43Z	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP	1W0775VX6E	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
DICHROMATE ION	9LKY4BFN2V	ACTIB
STRYCHNOS NUX-VOMICA SEED	269XH13919	ACTIB
PHYTOLACCA AMERICANA ROOT	11E6VI8VEG	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coldcalm	ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION	Laboratoires Boiron	af4a4765-8255-44fb-821c-4345a2a45e2a	2025-04-01	Warnings	Exact identifier ndc (package): 0220-9048-29 ndc (package): 0220-9048-04 ndc (package): 0220-9048-92 ndc (package): 0220-9048-91 ndc (product): 0220-9048 ndc11 (package): 00220904892 ndc11 (package): 00220904891 ndc11 (package): 00220904804 ndc11 (package): 00220904829 spl id: 31bbb16b-e155-90c4-e063-6394a90af542 spl set id: af4a4765-8255-44fb-821c-4345a2a45e2a

Reported adverse events (FAERS/openFDA)#

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