FDA.reportPublic FDA data

Cough Syrup Formula

Product NDC
43857-0548
11-digit product format
438570548
Labeler code
43857
Product ID
43857-0548_dee49bf1-2692-4b6f-ad0b-4c76659076b6
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
ATROPA BELLADONNA; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA WHOLE; MENTHA X PIPERITA WHOLE; PHOSPHORUS; POTASSIUM CARBONATE; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED
Active strength
6; 12; 4; 12; 12; 12; 5; 5 [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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cough Syrup Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DROSERA ROTUNDIFOLIA WHOLE6 [hp_X]/mL
PROTORTONIA CACTI12 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED4 [hp_X]/mL
ATROPA BELLADONNA12 [hp_X]/mL
CUPRIC ACETATE12 [hp_X]/mL
POTASSIUM CARBONATE12 [hp_X]/mL
MENTHA X PIPERITA WHOLE5 [hp_X]/mL
PHOSPHORUS5 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QR44N9XPJQInternal UNII lookup
LZB7TFX1LTInternal UNII lookup
1PIP394IIDInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
39M11XPH03Internal UNII lookup
BQN1B9B9HAInternal UNII lookup
79M2M2UDA9Internal UNII lookup
27YLU75U4WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ade129ac-3a50-47fe-87be-8efc3a64d2cdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0548-12024-01-05C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0548-12023-01-30C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0548-1Cough Syrup Formula120 mL in 1 BOTTLELIQUID1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0548COUGH SYRUP FORMULA (DROSERA (ROTUNDIFOLIA), COCCUS CACTI, SPONGIA TOSTA, BELLADONNA, CUPRUM ACETICUM, KALI CARBONICUM, MENTHA PIPERITA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240106_ade129ac-3a50-47fe-87be-8efc3a64d2cd.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough Syrup FormulaDROSERA (ROTUNDIFOLIA), COCCUS CACTI, SPONGIA TOSTA, BELLADONNA, CUPRUM ACETICUM, KALI CARBONICUM, MENTHA PIPERITA, PHOSPHORUSBioActive Nutritional, Inc.ade129ac-3a50-47fe-87be-8efc3a64d2cd2024-01-05WarningsExact identifier
ndc (product): 43857-0548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0548-143857054801120 mL in 1 BOTTLE (43857-0548-1) 120 ml2020-02-250000-00-00NoNoCurrent