Kids Cold and Cough Nighttime Grape Flavor

Product NDC
54973-4111
11-digit product format
549734111
Labeler code
54973
Product ID
54973-4111_e676dbb7-2130-47e3-e053-2995a90af4e1
Type
HUMAN OTC DRUG
Nonproprietary name
Onion, Chamomile, Arabica Coffee Bean, Calcium Sulfide, Golden Seal, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris Top, Sulfur
Dosage form
LIQUID
Route
ORAL
Labeler
Hyland's Consumer Health Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-12-01
Substance
ARABICA COFFEE BEAN; CALCIUM SULFIDE; CHAMOMILE; GOLDENSEAL; ONION; PHOSPHORUS; PULSATILLA VULGARIS TOP; SODIUM CHLORIDE; SULFUR
Active strength
6; 12; 6; 6; 6; 12; 6; 6; 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
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kids Cold and Cough Nighttime Grape Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARABICA COFFEE BEAN6 [hp_X]/mL
CALCIUM SULFIDE12 [hp_X]/mL
CHAMOMILE6 [hp_X]/mL
GOLDENSEAL6 [hp_X]/mL
ONION6 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PULSATILLA VULGARIS TOP6 [hp_X]/mL
SODIUM CHLORIDE6 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3SW678MX72, 1MBW07J51Q, FGL3685T2X, ZW3Z11D0JV, 492225Q21H, 27YLU75U4W, 4F1D271XW0, 451W47IQ8X, 70FD1KFU70

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4111-1Kids Cold and Cough Combo Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL3
54973-4111-1Kids Cold and Cough Combo Pack1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-4111-1Kids Cold and Cough Nighttime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1181
54973-4111-1Kids Cold and Cough Nighttime Grape Flavor1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4111KIDS COLD AND COUGH COMBO PACK (ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR) KIT [HYLAND'S CONSUMER HEALTH INC.]2Current NDC, Legacy NDC20230927_e6ffd6d1-fcfb-547d-e053-2995a90af9b6.zip
54973-4111KIDS COLD AND COUGH NIGHTTIME GRAPE FLAVOR (ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR) LIQUID [HYLAND'S CONSUMER HEALTH INC.]1Current NDC, Legacy NDC, 2 package rows20221201_e676dbb7-212f-47e3-e053-2995a90af4e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-4111-1549734111011 BOTTLE, PLASTIC in 1 CARTON (54973-4111-1) / 118 mL in 1 BOTTLE, PLASTIC2022-12-010000-00-00NoNoCurrent