FDA.reportPublic FDA data

COUGHTONE

Product NDC
44911-0593
11-digit product format
449110593
Labeler code
44911
Product ID
44911-0593_1da1f403-a018-4aeb-8ed3-3de8ef81ee07
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Lobelia Inflata, Antimonium Tartaricum, Aralia Racemosa, Drosera (Rotundifolia), Ipecacuanha, Kali Carbonicum, Phosphorus, Spongia Tosta
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-05-19
Substance
ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA WHOLE; IPECAC; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED
Active strength
12; 12; 12; 3; 12; 3; 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; [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
COUGHTONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA ANGUSTIFOLIA WHOLE12 [hp_X]/mL
LOBELIA INFLATA12 [hp_X]/mL
ANTIMONY POTASSIUM TARTRATE12 [hp_X]/mL
ARALIA RACEMOSA ROOT3 [hp_X]/mL
DROSERA ROTUNDIFOLIA12 [hp_X]/mL
IPECAC3 [hp_X]/mL
POTASSIUM CARBONATE12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB06AV5US8Internal UNII lookup
9PP1T3TC5UInternal UNII lookup
DL6OZ476V3Internal UNII lookup
T90W4582DUInternal UNII lookup
QR44N9XPJQInternal UNII lookup
62I3C8233LInternal UNII lookup
BQN1B9B9HAInternal UNII lookup
27YLU75U4WInternal UNII lookup
1PIP394IIDInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d4514ca-fbe0-4139-8151-aad039ccf05aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0593-12024-01-23C16284748780-1f386c649-ac23-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0593-12023-01-30C16284748780-1f386c649-ac23-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0593-1COUGHTONE30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0593COUGHTONE (ECHINACEA, LOBELIA INFLATA, ANTIMONIUM TARTARICUM, ARALIA RACEMOSA, DROSERA (ROTUNDIFOLIA), IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, SPONGIA TOSTA) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240124_0d4514ca-fbe0-4139-8151-aad039ccf05a.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
COUGHTONEECHINACEA, LOBELIA INFLATA, ANTIMONIUM TARTARICUM, ARALIA RACEMOSA, DROSERA (ROTUNDIFOLIA), IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, SPONGIA TOSTAEnergique, Inc.0d4514ca-fbe0-4139-8151-aad039ccf05a2024-01-23WarningsExact identifier
ndc (product): 44911-0593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0593-14491105930130 mL in 1 BOTTLE, GLASS (44911-0593-1) 30 ml2021-05-190000-00-00NoNoCurrent