FDA.reportPublic FDA data

Plantain Spruce Cough

Product NDC
48951-8390
11-digit product format
489518390
Labeler code
48951
Product ID
48951-8390_2b2402e5-9d9b-a55e-e063-6394a90a6214
Type
HUMAN OTC DRUG
Nonproprietary name
Plantain Spruce Cough
Dosage form
LIQUID
Route
ORAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-01-12
Substance
CINCHONA OFFICINALIS BARK; PICEA ABIES WHOLE; PROTORTONIA CACTI; IPECAC; PETASITES HYBRIDUS ROOT; SLOE; PLANTAGO LANCEOLATA WHOLE; MEPHITIS MEPHITIS ANAL GLAND FLUID; HELLEBORUS NIGER ROOT; VERATRUM ALBUM ROOT; DROSERA ROTUNDIFOLIA; ATROPA BELLADONNA
Active strength
5; 1; 5; 5; 1; 1; 1; 7; 5; 5; 4; 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; [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

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
Plantain Spruce Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINCHONA OFFICINALIS BARK5 [hp_X]/mL
PICEA ABIES WHOLE1 [hp_X]/mL
PROTORTONIA CACTI5 [hp_X]/mL
IPECAC5 [hp_X]/mL
PETASITES HYBRIDUS ROOT1 [hp_X]/mL
SLOE1 [hp_X]/mL
PLANTAGO LANCEOLATA WHOLE1 [hp_X]/mL
MEPHITIS MEPHITIS ANAL GLAND FLUID7 [hp_X]/mL
HELLEBORUS NIGER ROOT5 [hp_X]/mL
VERATRUM ALBUM ROOT5 [hp_X]/mL
DROSERA ROTUNDIFOLIA4 [hp_X]/mL
ATROPA BELLADONNA5 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S003A158SBInternal UNII lookup
D77PG8S4KKInternal UNII lookup
LZB7TFX1LTInternal UNII lookup
62I3C8233LInternal UNII lookup
97S2809V5RInternal UNII lookup
3MLB4858X7Internal UNII lookup
TJ55Y9N2M4Internal UNII lookup
3BN57UN4USInternal UNII lookup
608DGJ6815Internal UNII lookup
QNS6W5US1ZInternal UNII lookup
QR44N9XPJQInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6a99616-4a08-0909-e053-2995a90a0d2fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8390-1Plantain Spruce Cough125 mL in 1 BOTTLE, GLASSLIQUID1256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8390PLANTAIN SPRUCE COUGH LIQUID [URIEL PHARMACY INC.]6Current NDC, Legacy NDC, 1 package rows20250109_d6a99616-4a08-0909-e053-2995a90a0d2f.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
Plantain Spruce CoughPLANTAIN SPRUCE COUGHUriel Pharmacy Inc.d6a99616-4a08-0909-e053-2995a90a0d2f2025-01-07WarningsExact identifier
ndc (product): 48951-8390

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-8390-148951839001125 mL in 1 BOTTLE, GLASS (48951-8390-1) 125 ml2022-01-120000-00-00NoNoCurrent