FDA.reportPublic FDA data

Cough and Mucus Grape Flavor

Product NDC
54973-4056
11-digit product format
549734056
Labeler code
54973
Product ID
54973-4056_4254eeba-6fb5-d20f-e063-6394a90a5278
Type
HUMAN OTC DRUG
Nonproprietary name
ANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,FERROSOFERRIC PHOSPHATE,CALCIUM SULFIDE,IPECAC,PHOSPHORUS,ANEMONE PULSATILLA,RUMEX CRISPUS ROOT
Dosage form
LIQUID
Route
ORAL
Labeler
Hyland's
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-01
Substance
RUMEX CRISPUS ROOT; BRYONIA ALBA ROOT; ANEMONE PULSATILLA; PHOSPHORUS; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; IPECAC; ANTIMONY POTASSIUM TARTRATE
Active strength
6; 15; 12; 15; 12; 12; 12; 15 [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
Cough and Mucus Grape Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RUMEX CRISPUS ROOT6 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
ANEMONE PULSATILLA12 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
FERROSOFERRIC PHOSPHATE12 [hp_X]/mL
CALCIUM SULFIDE12 [hp_X]/mL
IPECAC12 [hp_X]/mL
ANTIMONY POTASSIUM TARTRATE15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9N1RM2S62CInternal UNII lookup
T7J046YI2BInternal UNII lookup
I76KB35JEVInternal UNII lookup
27YLU75U4WInternal UNII lookup
91GQH8I5F7Internal UNII lookup
1MBW07J51QInternal UNII lookup
62I3C8233LInternal UNII lookup
DL6OZ476V3Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0eb15c6-bf12-19b7-e053-2a95a90abbe0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4056-1Cough and Mucus Grape Flavor1 in 1 CARTONLIQUID110
54973-4056-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONLIQUID12 [hp_X] in 1mL10
54973-4056-1Cough and Mucus Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID11810
54973-4056-1Kids Cough and Mucus Day and Night Grape118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL10
54973-4056-2Kids Cough and Mucus Day and Night Grape5 mL in 1 POUCHLIQUID6 [hp_X] in 1mL10
54973-4056-3Cough and Mucus Grape Flavor5 mL in 1 POUCHLIQUID510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4056COUGH AND MUCUS GRAPE FLAVOR (ANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,FERROSOFERRIC PHOSPHATE,CALCIUM SULFIDE,IPECAC,PHOSPHORUS,ANEMONE PULSATILLA,RUMEX CRISPUS ROOT) LIQUID [HYLAND'S INC.]9Current NDC, Legacy NDC, 3 package rows20240504_d0eb15c6-bf12-19b7-e053-2a95a90abbe0.zip
54973-4056KIDS COUGH AND MUCUS DAY AND NIGHT GRAPE (RUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATE) KIT [HYLAND'S INC.]9Current NDC, Legacy NDC20250406_d92ab90b-b960-3df2-e053-2a95a90ace89.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 and Mucus Grape FlavorANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,FERROSOFERRIC PHOSPHATE,CALCIUM SULFIDE,IPECAC,PHOSPHORUS,ANEMONE PULSATILLA,RUMEX CRISPUS ROOTHyland'sd0eb15c6-bf12-19b7-e053-2a95a90abbe02025-10-29WarningsExact identifier
ndc (product): 54973-4056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4056-1549734056011 BOTTLE, PLASTIC in 1 CARTON (54973-4056-1) / 118 mL in 1 BOTTLE, PLASTIC2022-03-010000-00-00NoNoCurrent
54973-4056-2549734056025 mL in 1 POUCH5 mlHistorical
54973-4056-3549734056035 mL in 1 POUCH (54973-4056-3) 5 ml2025-10-29NoNoCurrent