Cough Syrup Formula
- Product NDC
- 43857-0548
- 11-digit product format
- 438570548
- Labeler code
- 43857
- Product ID
- 43857-0548_514c5a66-0a5a-4e96-b031-0cfa91a9e9c5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Drosera (Rotundifolia), Coccus Cacti, Spongia Tosta, Belladonna, Cuprum Aceticum, Kali Carbonicum, Mentha Piperita, Phosphorus
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- BioActive Nutritional, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2020-02-25
- Substance
- DROSERA ROTUNDIFOLIA WHOLE; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED; ATROPA BELLADONNA; CUPRIC ACETATE; POTASSIUM CARBONATE; MENTHA X PIPERITA WHOLE; PHOSPHORUS
- Active strength
- 4; 5; 5; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cough Syrup Formula
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DROSERA ROTUNDIFOLIA WHOLE | 4 [hp_X]/mL |
| PROTORTONIA CACTI | 5 [hp_X]/mL |
| SPONGIA OFFICINALIS SKELETON, ROASTED | 5 [hp_X]/mL |
| ATROPA BELLADONNA | 6 [hp_X]/mL |
| CUPRIC ACETATE | 12 [hp_X]/mL |
| POTASSIUM CARBONATE | 12 [hp_X]/mL |
| MENTHA X PIPERITA WHOLE | 12 [hp_X]/mL |
| PHOSPHORUS | 12 [hp_X]/mL |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43857-0548-1 | Cough Syrup Formula | 120 mL in 1 BOTTLE | LIQUID | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43857-0548 | COUGH SYRUP FORMULA (DROSERA (ROTUNDIFOLIA), COCCUS CACTI, SPONGIA TOSTA, BELLADONNA, CUPRUM ACETICUM, KALI CARBONICUM, MENTHA PIPERITA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240106_ade129ac-3a50-47fe-87be-8efc3a64d2cd.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43857-0548-1 | 43857054801 | 120 mL in 1 BOTTLE (43857-0548-1) | 120 ml | 2020-02-25 | 0000-00-00 | No | No | Current |