Home NDC 54973-3316-1 4 Kids Oral Pain Relief
Product NDC 54973-3316
Requested package NDC 54973-3316-1
11-digit product format 549733316
Labeler code 54973
Product ID 54973-3316_ee17f29f-b5c9-5b63-e053-2a95a90ac63b
Type HUMAN OTC DRUG
Nonproprietary name Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum and Matricaria Chamomilla
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; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE
Active strength 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54973-3316 54973-3316-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 54973-3316 4 KIDS ORAL PAIN RELIEF (OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARABICA COFFEE BEAN, ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA) TABLET [HYLAND'S INC.] 5 Legacy NDC 20221124_58ece525-b626-fa51-e053-2991aa0a35ef.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54973-3316-1 54973331601 1 BOTTLE, PLASTIC in 1 CARTON (54973-3316-1) > 125 g in 1 BOTTLE, PLASTIC 2017-08-18 0000-00-00 No No Current