Coldcalm
- Product NDC
- 0220-9048
- Requested package NDC
- 0220-9048-29
- 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 |
|---|---|
| ONION | 6 [hp_C]/1 |
| APIS MELLIFERA | 6 [hp_C]/1 |
| ATROPA BELLADONNA | 6 [hp_C]/1 |
| EUPATORIUM PERFOLIATUM FLOWERING TOP | 3 [hp_C]/1 |
| GELSEMIUM SEMPERVIRENS ROOT | 6 [hp_C]/1 |
| DICHROMATE ION | 3 [hp_C]/1 |
| STRYCHNOS NUX-VOMICA SEED | 6 [hp_C]/1 |
| PHYTOLACCA AMERICANA ROOT | 6 [hp_C]/1 |
| PULSATILLA VULGARIS | 3 [hp_C]/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 492225Q21H | Internal UNII lookup |
| 7S82P3R43Z | Internal UNII lookup |
| WQZ3G9PF0H | Internal UNII lookup |
| 1W0775VX6E | Internal UNII lookup |
| 639KR60Q1Q | Internal UNII lookup |
| 9LKY4BFN2V | Internal UNII lookup |
| 269XH13919 | Internal UNII lookup |
| 11E6VI8VEG | Internal UNII lookup |
| I76KB35JEV | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| af4a4765-8255-44fb-821c-4345a2a45e2a | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| 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 | Form | Quantity | Strength | 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 Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| 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 |
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, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION | Laboratoires Boiron | af4a4765-8255-44fb-821c-4345a2a45e2a | 2025-04-01 | Warnings | 0220-9048-29 0220-9048 00220904829 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0220-9048-29 | 00220904829 | 120 TABLET in 1 BLISTER PACK (0220-9048-29) | 120 tablet | 2020-12-09 | 0000-00-00 | No | No | Current |