SAPONARIA OFFICINALIS
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2023-11-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:24:30
Label at a glance#
ProductSAPONARIA OFFICINALIS
Active ingredientSAPONARIA OFFICINALIS ROOT
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
SAPONARIA OFFICINALIS
(**contains 0.443 mg of the active ingredient per pellet)
INDICATIONS & USAGE SECTION
Skin Rash With Itching*
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
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.
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
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
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 |
|---|---|---|---|---|---|
| 0220-4560-41 | 2023-11-14 | C162847 | 48780-1 | f386c649-acff-0266-e053-dadaa90a7c1a | SAPONARIA OFFICINALIS 9C |
| 0220-4560-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-acff-0266-e053-dadaa90a7c1a | SAPONARIA OFFICINALIS 9C |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-4560-41 | SAPONARIA OFFICINALIS | 9 [hp_C] in 1 TUBE | PELLET | 9 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- SAPONARIA OFFICINALIS
- SAPONARIA OFFICINALIS ROOT
- LACTOSE, UNSPECIFIED FORM
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-4560 | 0220-4560-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | IACT |
| SAPONARIA OFFICINALIS ROOT | RI2K1BMA8B | 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 |
|---|---|---|---|---|---|---|
| SAPONARIA OFFICINALIS | SAPONARIA OFFICINALIS ROOT | Boiron | a7d10bca-e3e5-985c-e053-2a95a90aa717 | 2023-11-14 | 0220-4560-41 0220-4560 00220456041 0a24b0cb-2898-9489-e063-6294a90a77c0 a7d10bca-e3e5-985c-e053-2a95a90aa717 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.