Home NDC 54973-3324 Baby Nighttime Oral Pain Relief
Product NDC 54973-3324
11-digit product format 549733324
Labeler code 54973
Product ID 54973-3324_308ccf50-c319-2cd0-e063-6394a90aa99e
Type HUMAN OTC DRUG
Nonproprietary name Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude
Dosage form TABLET
Route ORAL
Labeler Hyland' Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-08-17
Substance ARABICA COFFEE BEAN; ARNICA MONTANA; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE
Active strength 6; 30; 12; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 Oral Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE 6 [hp_X]/g TRIBASIC CALCIUM PHOSPHATE 30 [hp_X]/g MATRICARIA CHAMOMILLA 12 [hp_X]/g SILICON DIOXIDE 12 [hp_X]/g ARNICA MONTANA 12 [hp_X]/g FERROSOFERRIC PHOSPHATE 12 [hp_X]/g ARABICA COFFEE BEAN 12 [hp_X]/g MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 8 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 54973-3324-1 Baby Nighttime Oral Pain Relief 1 g in 1 BOTTLE, PLASTIC TABLET 1 13 54973-3324-1 Baby Nighttime Oral Pain Relief 1 in 1 CARTON TABLET 1 13 54973-3324-4 Baby Nighttime Oral Pain Relief 6 g in 1 PACKET TABLET 6 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3324 BABY NIGHTTIME ORAL PAIN RELIEF (ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE) TABLET [HYLAND' INC.] 13 Current NDC, Legacy NDC, 3 package rows 20250321_58ef86b7-5b38-1591-e053-2991aa0aa53e.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 Oral Pain Relief ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE Hyland' Inc. 58ef86b7-5b38-1591-e053-2991aa0aa53e 2025-03-17 Warnings Exact identifier ndc (product): 54973-3324
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3324-1 54973332401 1 BOTTLE, PLASTIC in 1 CARTON (54973-3324-1) / 1 g in 1 BOTTLE, PLASTIC 2017-08-17 0000-00-00 No No Current 54973-3324-4 54973332404 6 g in 1 PACKET (54973-3324-4) 6 g 2017-08-17 0000-00-00 Yes No Current