Home NDC 54973-3375-2 4 Kids Cold and Cough Nighttime
Product NDC 54973-3375
Requested package NDC 54973-3375-2
11-digit product format 549733375
Labeler code 54973
Product ID 54973-3375_2d83102a-9c33-5246-e063-6294a90ac8df
Type HUMAN OTC DRUG
Nonproprietary name ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS and GOLDENSEAL
Dosage form LIQUID
Route ORAL
Labeler Hyland's Consumer Health Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2018-07-01
Substance ANEMONE PULSATILLA; ARABICA COFFEE BEAN; CALCIUM SULFIDE; GOLDENSEAL; MATRICARIA CHAMOMILLA; ONION; PHOSPHORUS; SODIUM CHLORIDE; SULFUR
Active strength 6; 6; 12; 6; 6; 6; 12; 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Additional Listing Data#
Finished product Yes
Brand name base 4 Kids Cold and Cough Nighttime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ONION 6 [hp_X]/mL CALCIUM SULFIDE 6 [hp_X]/mL SODIUM CHLORIDE 12 [hp_X]/mL ANEMONE PULSATILLA 6 [hp_X]/mL MATRICARIA CHAMOMILLA 6 [hp_X]/mL GOLDENSEAL 6 [hp_X]/mL ARABICA COFFEE BEAN 12 [hp_X]/mL PHOSPHORUS 6 [hp_X]/mL SULFUR 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 54973-3375-1 4 Kids Cold and Cough Nighttime 1 in 1 CARTON LIQUID 1 11 54973-3375-1 4 Kids Cold and Cough Nighttime 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 11 54973-3375-2 4 Kids Cold and Cough Nighttime 5 mL in 1 PACKET LIQUID 5 11 54973-3375-3 4 Kids Cold and Cough Nighttime 1 in 1 CARTON LIQUID 1 11 54973-3375-3 4 Kids Cold and Cough Nighttime 148 mL in 1 BOTTLE, PLASTIC LIQUID 148 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3375 4 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.] 11 Current NDC, Legacy NDC, 5 package rows 20250209_71e93027-33c9-6147-e053-2a95a90aaa09.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3375-2 54973337502 5 mL in 1 PACKET (54973-3375-2) 5 ml 2018-07-01 0000-00-00 Yes No Current