FDA.reportPublic FDA data

Kids Cough and Mucus Nighttime Grape Flavor

Product NDC
54973-4057
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
ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; IPECAC; MATRICARIA CHAMOMILLA WHOLE; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT
Active strength
15; 15; 12; 12; 15; 12; 6; 15; 12; 6 [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

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDL6OZ476V3, T7J046YI2B, 1MBW07J51Q, 91GQH8I5F7, ZW3Z11D0JV, 62I3C8233L, G0R4UBI2ZZ, 27YLU75U4W, I76KB35JEV, 9N1RM2S62C

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4057-1549734057011 BOTTLE, PLASTIC in 1 CARTON (54973-4057-1) / 118 mL in 1 BOTTLE, PLASTIC2022-03-010000-00-00NoNoCurrent
54973-4057-2549734057025 mL in 1 POUCH5 mlHistorical
54973-4057-3549734057031 POUCH in 1 CARTON (54973-4057-3) / 5 mL in 1 POUCH1 pouch2025-10-29NoNoHistorical