AM-4
- Product NDC
- 58264-0343
- 11-digit product format
- 582640343
- Labeler code
- 58264
- Product ID
- 58264-0343_2b5306f6-76b3-a89c-e063-6294a90aebfb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- VISCUM ALBUM WHOLE, CALCIUM FLUORIDE, and ANDROCTONUS AUSTRALIS WHOLE
- Dosage form
- SOLUTION
- Route
- SUBLINGUAL
- Labeler
- DNA Labs, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 1990-01-01
- Substance
- ANDROCTONUS AUSTRALIS WHOLE; CALCIUM FLUORIDE; VISCUM ALBUM WHOLE
- Active strength
- 12; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AM-4
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ANDROCTONUS AUSTRALIS WHOLE | 12 [hp_X]/mL |
| CALCIUM FLUORIDE | 8 [hp_X]/mL |
| VISCUM ALBUM WHOLE | 12 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9E33CYO50W, O3B55K4YKI, E6839Q6DO1 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58264-0343-1 | AM-4 | 29.57 mL in 1 BOTTLE, GLASS | SOLUTION | 29.57 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58264-0343 | AM-4 (VISCUM ALBUM WHOLE, CALCIUM FLUORIDE, AND ANDROCTONUS AUSTRALIS WHOLE) SOLUTION [DNA LABS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250112_3aa36f14-d374-49e3-bcc9-b9f0496792e7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58264-0343-1 | 58264034301 | 29.57 mL in 1 BOTTLE, GLASS (58264-0343-1) | 29.57 ml | 1990-01-01 | 0000-00-00 | No | No | Current |