D-16
- Product NDC
- 58264-0016
- 11-digit product format
- 582640016
- Labeler code
- 58264
- Product ID
- 58264-0016_2b9ea65c-9dfc-ad89-e063-6394a90ab44c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia
- Dosage form
- SOLUTION/ DROPS
- Route
- SUBLINGUAL
- Labeler
- DNA Labs, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 1990-01-01
- Substance
- BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA
- Active strength
- 4; 3; 2; 2; 4 [hp_X]/mL; [hp_X]/mL; [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
- D-16
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BLACK COHOSH | 4 [hp_X]/mL |
| GELSEMIUM SEMPERVIRENS ROOT | 3 [hp_X]/mL |
| IRIS VERSICOLOR ROOT | 2 [hp_X]/mL |
| SANGUINARIA CANADENSIS ROOT | 2 [hp_X]/mL |
| SPIGELIA ANTHELMIA | 4 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K73E24S6X9, 639KR60Q1Q, X43D4L3DQC, N9288CD508, WYT05213GE |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58264-0016-1 | D-16 | 29.57 mL in 1 BOTTLE, GLASS | SOLUTION/ DROPS | 29.57 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58264-0016 | D-16 (BLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, AND SPIGELIA ANTHELMIA) SOLUTION/ DROPS [DNA LABS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250115_4784ddc2-c308-4092-a01f-ea2b2954a888.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58264-0016-1 | 58264001601 | 29.57 mL in 1 BOTTLE, GLASS (58264-0016-1) | 29.57 ml | 1990-01-01 | 0000-00-00 | No | No | Current |