Home NDC 54973-3392 4 Kids Earache Relief
Product NDC 54973-3392
11-digit product format 549733392
Labeler code 54973
Product ID 54973-3392_ee179f50-a7e0-8a0f-e053-2a95a90a876e
Type HUMAN OTC DRUG
Nonproprietary name ATROPA BELLADONNA,OYSTER SHELL CALCIUM CARBONATE, CRUDE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PULSATILLA,SULFUR and MATRICARIA CHAMOMILLA
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler Hyland
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-03-01
Marketing end 0000-00-00
Substance ANEMONE PULSATILLA; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SULFUR
Active strength 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
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 · 2 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 product product 54973-3392 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54973-3392 54973-3392-1 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3392 4 KIDS EARACHE RELIEF (ATROPA BELLADONNA,OYSTER SHELL CALCIUM CARBONATE, CRUDE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PULSATILLA,SULFUR AND MATRICARIA CHAMOMILLA) LIQUID [HYLAND’S] 5 Legacy NDC 20221124_7ee2a9f8-4a16-4a9d-e053-2a91aa0a1be7.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54973-3392-1 54973339201 1 BOTTLE, DROPPER in 1 CARTON (54973-3392-1) > 10 mL in 1 BOTTLE, DROPPER 2019-03-01 0000-00-00 No No Current