Home NDC 54973-3371-3 Baby Nighttime Mucus Plus Cold Relief
Product NDC 54973-3371
Requested package NDC 54973-3371-3
11-digit product format 549733371
Labeler code 54973
Product ID 54973-3371_f98bd339-1709-6f48-e053-6394a90ad617
Type HUMAN OTC DRUG
Nonproprietary name CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA and MATRICARIA CHAMOMILLA
Dosage form LIQUID
Route ORAL
Labeler Hyland's Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2018-11-01
Substance ANEMONE PULSATILLA; ARABICA COFFEE BEAN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; EUPHRASIA STRICTA; GOLDENSEAL; MATRICARIA CHAMOMILLA; ONION; PHOSPHORUS; RUMEX CRISPUS ROOT; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR
Active strength 6; 3; 6; 12; 6; 6; 3; 6; 30; 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; [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 Baby Nighttime Mucus Plus Cold Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM SULFIDE 6 [hp_X]/mL PHOSPHORUS 3 [hp_X]/mL ANEMONE PULSATILLA 6 [hp_X]/mL SILICON DIOXIDE 12 [hp_X]/mL GOLDENSEAL 6 [hp_X]/mL ONION 6 [hp_X]/mL BRYONIA ALBA ROOT 3 [hp_X]/mL EUPHRASIA STRICTA 6 [hp_X]/mL MATRICARIA CHAMOMILLA 30 [hp_X]/mL ARABICA COFFEE BEAN 6 [hp_X]/mL SODIUM CHLORIDE 12 [hp_X]/mL RUMEX CRISPUS ROOT 6 [hp_X]/mL SULFUR 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 13 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54973-3371-1 Baby Nighttime Mucus Plus Cold Relief 1 in 1 CARTON LIQUID 1 7 54973-3371-1 Baby Nighttime Mucus Plus Cold Relief 148 mL in 1 BOTTLE, PLASTIC LIQUID 148 7 54973-3371-2 Baby Nighttime Mucus Plus Cold Relief 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 7 54973-3371-2 Baby Nighttime Mucus Plus Cold Relief 1 in 1 CARTON LIQUID 1 7 54973-3371-2 BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME 118 mL in 1 BOTTLE LIQUID 118 mL 6 [hp_X] in 1mL 7 54973-3371-3 Baby Nighttime Mucus Plus Cold Relief 2.5 mL in 1 PACKET LIQUID 2.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3371 BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA) KIT [HYLAND'S INC.] 7 Current NDC, Legacy NDC 20230901_7979fc6f-6d2c-56c9-e053-2991aa0ac1f3.zip 54973-3371 BABY NIGHTTIME MUCUS PLUS COLD RELIEF (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA) LIQUID [HYLAND'S INC.] 7 Current NDC, Legacy NDC, 5 package rows 20230419_736b2487-e81d-d172-e053-2a91aa0ab0cf.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 Baby Nighttime Mucus Plus Cold Relief CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA Hyland's Inc. 736b2487-e81d-d172-e053-2a91aa0ab0cf 2023-04-17 Warnings Exact identifier ndc (package): 54973-3371-3 ndc (product): 54973-3371 ndc11 (package): 54973337103
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3371-3 54973337103 2.5 mL in 1 PACKET (54973-3371-3) 2.5 ml 2018-11-01 0000-00-00 Yes No Current