Home NDC 54973-3325-3 4 Kids Oral Pain Relief Nighttime
Product NDC 54973-3325
Requested package NDC 54973-3325-3
11-digit product format 549733325
Labeler code 54973
Product ID 54973-3325_ee180cdd-90b8-b803-e053-2a95a90aec8c
Type HUMAN OTC DRUG
Nonproprietary name arnica montana,tribasic calcium phosphate,silicon dioxide,matricaria chamomilla,ferrum phosphoricum,arabica coffee bean,magnesium phosphate, dibasic trihydrate and oyster shell calcium carbonate, crude
Dosage form TABLET
Route ORAL
Labeler Hyland's Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-08-18
Marketing end 0000-00-00
Substance ARABICA COFFEE BEAN; ARNICA MONTANA; FERRUM PHOSPHORICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE
Active strength 6 [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 2023-12-31
Current FDA listing Historical FDA.report record
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3325 4 KIDS ORAL PAIN RELIEF NIGHTTIME (ARNICA MONTANA,TRIBASIC CALCIUM PHOSPHATE,SILICON DIOXIDE,MATRICARIA CHAMOMILLA,FERRUM PHOSPHORICUM,ARABICA COFFEE BEAN,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND OYSTER SHELL CALCIUM CARBONATE, CRUDE) TABLET [HYLAND'S INC.] 5 Legacy NDC 20221124_58b2bd93-e980-ed15-e053-2991aa0aca03.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3325-3 54973332503 6 g in 1 PACKET (54973-3325-3) 6 g 2017-08-18 0000-00-00 Yes No Current