Actaea spicata
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2025-07-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:34:50
Label at a glance#
ProductActaea spicata
Active ingredientACTAEA SPICATA ROOT
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Actaea spicata 6C HPUS
Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).
INDICATIONS & USAGE SECTION
Relieves minor arthritis pain in fingers and toes *
Uses: See symptoms on front panel.
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.
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
SPL UNCLASSIFIED SECTION
Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*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
lactose, sucrose
DOSAGE & ADMINISTRATION SECTION
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
OTC - QUESTIONS SECTION
BoironUSA.com Info@boiron.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-0053-41 | 2023-07-12 | C162847 | 48780-1 | f386c64a-2bc0-0266-e053-dadaa90a7c1a | Actaea spicata 6c |
| 0220-0053-41 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2bc0-0266-e053-dadaa90a7c1a | Actaea spicata 6c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-0053-41 | Actaea spicata | 6 [hp_C] in 1 TUBE | PELLET | 6 | 3 |
Products#
Every source-derived product name is available through these pages.
- Actaea spicata
- ACTAEA SPICATA ROOT
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-0053 | 0220-0053-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | IACT |
| ACTAEA SPICATA ROOT | 3FU86L9OS0 | 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 |
|---|---|---|---|---|---|---|
| Actaea spicata | ACTAEA SPICATA ROOT | Boiron | 83e7ef0c-892f-423d-e053-2991aa0ab888 | 2025-07-01 | 0220-0053-41 0220-0053 00220005341 38e08dc1-9e5d-cf3b-e063-6294a90ab003 83e7ef0c-892f-423d-e053-2991aa0ab888 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.