Home NDC 54973-7516-3 BABY INFANT EARACHE DROPS
Product NDC 54973-7516
Requested package NDC 54973-7516-3
11-digit product format 549737516
Labeler code 54973
Product ID 54973-7516_ee8d0910-e9ad-0692-e053-2a95a90a6d8c
Type HUMAN OTC DRUG
Nonproprietary name belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler Hyland's Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2004-03-16
Marketing end 0000-00-00
Substance BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PATENS WHOLE; SULFUR
Active strength 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [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 · 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 package package 54973-7516 54973-7516-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54973-7516 54973-7516-3 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ANEMONE PATENS ACTIVE INGREDIENT 4M1169RWJD BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 BELLADONNA LEAF ACTIVE INGREDIENT 6GZW20TIOI BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 CALCIUM CARBONATE ACTIVE INGREDIENT H0G9379FGK BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 CHAMOMILE ACTIVE INGREDIENT FGL3685T2X BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 LYCOPODIUM CLAVATUM SPORE ACTIVE INGREDIENT C88X29Y479 BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 SULFUR ACTIVE INGREDIENT 70FD1KFU70 BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 ANEMONE PATENS ACTIVE MOIETY 4M1169RWJD BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 BELLADONNA LEAF ACTIVE MOIETY 6GZW20TIOI BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 CHAMOMILE ACTIVE MOIETY FGL3685T2X BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 LYCOPODIUM CLAVATUM SPORE ACTIVE MOIETY C88X29Y479 BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 SULFUR ACTIVE MOIETY 70FD1KFU70 BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3 WATER INACTIVE INGREDIENT 059QF0KO0R BABY INFANT EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54973-7516-3 54973751603 1 BOTTLE, DROPPER in 1 CARTON (54973-7516-3) > 10 mL in 1 BOTTLE, DROPPER 2004-03-16 0000-00-00 No No Current