Storage and handling
SHAKE WELL
AM-11
- Manufacturer
- DNA Labs, Inc.
- Effective date
- 2025-01-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:31:01
Label at a glance#
ProductAM-11
Active ingredientARNICA MONTANA, SODIUM CHLORIDE, APIS MELLIFERA
Label structure8 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
NDC 58264-0350-1
INDICATIONS & USAGE SECTION
INDICATIONS
Regulates energy flow in the kidney meridian.
INGREDIENTS
INACTIVE INGREDIENT SECTION
Arnica montana 8x, Natrum chloratum 8x, Apis mellifica 12x, aa partes, 20% alcohol in purified water.
SUGGESTED DOSAGE
5 to 10 drops twice a day, meridian energy excess 1 to 5 drops t.i.d, meridian lacking in energy 10 to 20 drops t.i.d.
STORAGE AND HANDLING SECTION
SHAKE WELL
Warnings
- Use only if cap seal is unbroken.
OTC - PREGNANCY OR BREAST FEEDING SECTION
- As with drugs if you are pregnant or nursing a baby seek professional advice before using this product.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep this and all medication out of the reach of children.
SPL UNCLASSIFIED SECTION
To be used according to standard homeopathic indications.
PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
DYNAMIC
NUTRITIONAL
ASSOCIATES, INC.
AM-11
KIDNEY
ACUPUNCTURE MERIDIAN
1 FL. OZ.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58264-0350-1 | 2022-06-02 | C162847 | 48780-1 | 9d75b9d1-1848-f424-e053-dadaa90a57ce | AM-11 |
| 58264-0350-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1848-f424-e053-dadaa90a57ce | AM-11 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58264-0350-1 | AM-11 | 29.57 mL in 1 BOTTLE, GLASS | SOLUTION | 29.57 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58264-0350 | AM-11 (ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERA) SOLUTION [DNA LABS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250112_c072811b-6259-4b22-b364-50369dc68fb0.zip |
Products#
Every source-derived product name is available through these pages.
- AM-11
- Arnica Montana, Sodium Chloride, and APIS MELLIFERA
- ALCOHOL
- WATER
- ARNICA MONTANA
- ARNICA MONTANA ROOT
- SODIUM CHLORIDE
- CHLORIDE ION
- SODIUM CATION
- APIS MELLIFERA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58264-0350 | 58264-0350-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| APIS MELLIFERA | 7S82P3R43Z | 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 |
|---|---|---|---|---|---|---|
| AM-11 | ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERA | DNA Labs, Inc. | c072811b-6259-4b22-b364-50369dc68fb0 | 2025-01-09 | Warnings | 58264-0350-1 58264-0350 58264035001 2b52fd6d-8b0c-27a7-e063-6394a90a6a9e c072811b-6259-4b22-b364-50369dc68fb0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.