COLDCALM
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2025-04-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:33:26
Label at a glance#
ProductCOLDCALM
Active ingredientPHYTOLACCA AMERICANA ROOT, APIS MELLIFERA, ATROPA BELLADONNA, ONION, PULSATILLA VULGARIS, POTASSIUM DICHROMATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED
Label structure14 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients** (in each pellet)
Allium cepa 3C HPUS (0.05 mg)
Apis mellifica 6C HPUS (0.05 mg)
Belladonna 6C HPUS (0.05 mg)(contains less than 10 -15 mg atropine alkaloids)
Eupatorium perfoliatum 3C HPUS (0.05 mg)
Gelsemium sempervirens 6C HPUS (0.05 mg)
Kali bichromicum 6C HPUS (0.05 mg)
Nux vomica 3C HPUS (0.05 mg) (contains less than 10 -8 mg strychnine alkaloids)
Phytolacca decandra 6C HPUS (0.05 mg)
Pulsatilla 6C HPUS (0.05 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*
Relieves Cold Symptoms: Sneezing, Runny Nose, Occasional Minor Sore Throat, and Congestion
INDICATIONS & USAGE SECTION
Uses*
temporarily relieves cold symptoms such as:
▪ sneezing ▪ runny nose ▪ nasal congestion ▪ occasional minor sore throat t
WARNINGS SECTION
Do not use if you are allergic to Apis.
OTC - ASK DOCTOR SECTION
Ask a doctor before use 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 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue every 6 hours. Decrease frequency with improvement.
- Children under 4 years of age: Ask a doctor.
SPL UNCLASSIFIED SECTION
Other information
- do not use if glued carton end flaps are open or if pellet dispenser seal is broken
- contains 0.25 g of sugar per dose
INACTIVE INGREDIENT SECTION
lactose, sucrose
OTC - QUESTIONS SECTION
Questions or comments?
1-800-264-7661
Made in France
Distributed by
Boiron Inc.
Newtown Square, PA
19073
SPL UNCLASSIFIED SECTION
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Multi-Symptom Cold Relief*
No Known Drug Interactions
*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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9098-41 | COLDCALM | 80 in 1 TUBE | PELLET | 80 | 3 | |
| 0220-9098-42 | COLDCALM | 2 in 1 BOX | PELLET | 2 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0220-9098 | COLDCALM (ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLE) PELLET [BOIRON] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250417_da32d4e3-f049-e7c8-e053-2a95a90a5790.zip |
Products#
Every source-derived product name is available through these pages.
- COLDCALM
- ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLE
- PHYTOLACCA AMERICANA ROOT
- APIS MELLIFERA
- ATROPA BELLADONNA
- ONION
- PULSATILLA VULGARIS
- SUCROSE
- POTASSIUM DICHROMATE
- DICHROMATE ION
- LACTOSE, UNSPECIFIED FORM
- EUPATORIUM PERFOLIATUM FLOWERING TOP
- GELSEMIUM SEMPERVIRENS ROOT
- STRYCHNOS NUX-VOMICA SEED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9098 | 0220-9098-41, 0220-9098-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHYTOLACCA AMERICANA ROOT | 11E6VI8VEG | ACTIB |
| APIS MELLIFERA | 7S82P3R43Z | ACTIB |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| ONION | 492225Q21H | ACTIB |
| PULSATILLA VULGARIS | I76KB35JEV | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| POTASSIUM DICHROMATE | T4423S18FM | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| EUPATORIUM PERFOLIATUM FLOWERING TOP | 1W0775VX6E | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
Source Document#
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.
| 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, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLE | Boiron | da32d4e3-f049-e7c8-e053-2a95a90a5790 | 2025-04-15 | Warnings | 0220-9098-41 0220-9098-42 0220-9098 00220909842 00220909841 32d4e0c8-f244-c359-e063-6294a90a5f2a da32d4e3-f049-e7c8-e053-2a95a90a5790 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.