FDA.reportPublic FDA data

Kids Cough and Mucus Nighttime Grape Flavor

Product NDC
54973-4057
Requested package NDC
54973-4057-1
11-digit product format
549734057
Labeler code
54973
Product ID
54973-4057_4b30bf8c-4f50-f880-e063-6294a90a8f77
Type
HUMAN OTC DRUG
Nonproprietary name
RUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATE
Dosage form
LIQUID
Route
ORAL
Labeler
Hyland's Consumer Health Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-01
Substance
RUMEX CRISPUS ROOT; IPECAC; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA WHOLE; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; PULSATILLA VULGARIS; GOLDENSEAL; PHOSPHORUS
Active strength
6; 12; 15; 15; 6; 12; 12; 12; 15; 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; [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
Kids Cough and Mucus Nighttime Grape Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RUMEX CRISPUS ROOT6 [hp_X]/mL
IPECAC12 [hp_X]/mL
ANTIMONY POTASSIUM TARTRATE15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE6 [hp_X]/mL
FERROSOFERRIC PHOSPHATE12 [hp_X]/mL
CALCIUM SULFIDE12 [hp_X]/mL
PULSATILLA VULGARIS12 [hp_X]/mL
GOLDENSEAL15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9N1RM2S62CInternal UNII lookup
62I3C8233LInternal UNII lookup
DL6OZ476V3Internal UNII lookup
T7J046YI2BInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
91GQH8I5F7Internal UNII lookup
1MBW07J51QInternal UNII lookup
I76KB35JEVInternal UNII lookup
ZW3Z11D0JVInternal 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
d83e7877-f599-b364-e053-2995a90ab35fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4057-1Kids Cough and Mucus Nighttime Grape Flavor1 in 1 CARTONLIQUID110
54973-4057-1Kids Cough and Mucus Day and Night Grape118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL10
54973-4057-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONLIQUID15 [hp_X] in 1mL10
54973-4057-1Kids Cough and Mucus Nighttime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID11810
54973-4057-2Kids Cough and Mucus Day and Night Grape5 mL in 1 POUCHLIQUID6 [hp_X] in 1mL10
54973-4057-3Kids Cough and Mucus Nighttime Grape Flavor1 in 1 CARTONLIQUID110
54973-4057-3Kids Cough and Mucus Nighttime Grape Flavor5 mL in 1 POUCHLIQUID510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4057KIDS 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
54973-4057KIDS COUGH AND MUCUS NIGHTTIME GRAPE FLAVOR (RUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATE) LIQUID [HYLAND'S CONSUMER HEALTH INC.]8Current NDC, Legacy NDC, 4 package rows20240504_d83e7877-f599-b364-e053-2995a90ab35f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Cough and Mucus Nighttime Grape FlavorRUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATEHyland's Consumer Health Inc.d83e7877-f599-b364-e053-2995a90ab35f2026-02-19WarningsExact identifier
ndc (package): 54973-4057-1
ndc (product): 54973-4057
ndc11 (package): 54973405701
Kids Cough and Mucus Day and Night GrapeRUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATEHyland's Inc.d92ab90b-b960-3df2-e053-2a95a90ace892025-06-25WarningsExact identifier
ndc (package): 54973-4057-1
ndc11 (package): 54973405701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-4057-1549734057011 BOTTLE, PLASTIC in 1 CARTON (54973-4057-1) / 118 mL in 1 BOTTLE, PLASTIC2022-03-010000-00-00NoNoCurrent