Home NDC 54973-4111 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 Ingredient Strength CALCIUM SULFIDE 6 [hp_X]/mL GOLDENSEAL 12 [hp_X]/mL CHAMOMILE 6 [hp_X]/mL SODIUM CHLORIDE 6 [hp_X]/mL ONION 6 [hp_X]/mL ARABICA COFFEE BEAN 12 [hp_X]/mL PULSATILLA VULGARIS TOP 6 [hp_X]/mL SULFUR 6 [hp_X]/mL PHOSPHORUS 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54973-4111-1 Kids Cold and Cough Combo Pack 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 mL 12 [hp_X] in 1mL 3 54973-4111-1 Kids Cold and Cough Combo Pack 1 in 1 CARTON LIQUID 6 [hp_X] in 1mL 3 54973-4111-1 Kids Cold and Cough Nighttime Grape Flavor 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 1 54973-4111-1 Kids Cold and Cough Nighttime Grape Flavor 1 in 1 CARTON LIQUID 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-4111 KIDS 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.] 2 Current NDC, Legacy NDC 20230927_e6ffd6d1-fcfb-547d-e053-2995a90af9b6.zip 54973-4111 KIDS 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.] 1 Current NDC, Legacy NDC, 2 package rows 20221201_e676dbb7-212f-47e3-e053-2995a90af4e1.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kids Cold and Cough Nighttime Grape Flavor ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR Hyland's Consumer Health Inc. e676dbb7-212f-47e3-e053-2995a90af4e1 2022-08-17 Warnings Exact identifier ndc (product): 54973-4111
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54973-4111-1 54973411101 1 BOTTLE, PLASTIC in 1 CARTON (54973-4111-1) / 118 mL in 1 BOTTLE, PLASTIC 2022-12-01 0000-00-00 No No Current