Home NDC 54973-3172 EARACHE DROPS
Product NDC 54973-3172
11-digit product format 549733172
Labeler code 54973
Product ID 54973-3172_efa40953-abb8-885e-e053-2a95a90a6482
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 2004-06-17
Substance ANEMONE PATENS WHOLE; BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; SULFUR
Active strength 30; 30; 30; 30; 30; 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 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 EARACHE DROPS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BELLADONNA LEAF 30 [hp_C]/mL CALCIUM CARBONATE 30 [hp_C]/mL CHAMOMILE 30 [hp_C]/mL LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL ANEMONE PATENS WHOLE 30 [hp_C]/mL SULFUR 30 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 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 54973-3172-1 EARACHE DROPS 1 in 1 CARTON LIQUID 1 9 54973-3172-1 EARACHE DROPS 10 mL in 1 BOTTLE, DROPPER LIQUID 10 9 54973-3172-2 EARACHE DROPS 1 in 1 CARTON LIQUID 1 9 54973-3172-2 EARACHE DROPS 12 mL in 1 BOTTLE, DROPPER LIQUID 12 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ANEMONE PATENS ACTIVE INGREDIENT 4M1169RWJD EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 BELLADONNA LEAF ACTIVE INGREDIENT 6GZW20TIOI EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 CALCIUM CARBONATE ACTIVE INGREDIENT H0G9379FGK EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 CHAMOMILE ACTIVE INGREDIENT FGL3685T2X EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 LYCOPODIUM CLAVATUM SPORE ACTIVE INGREDIENT C88X29Y479 EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 SULFUR ACTIVE INGREDIENT 70FD1KFU70 EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 ANEMONE PATENS ACTIVE MOIETY 4M1169RWJD EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 BELLADONNA LEAF ACTIVE MOIETY 6GZW20TIOI EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 CHAMOMILE ACTIVE MOIETY FGL3685T2X EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 LYCOPODIUM CLAVATUM SPORE ACTIVE MOIETY C88X29Y479 EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 SULFUR ACTIVE MOIETY 70FD1KFU70 EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2 WATER INACTIVE INGREDIENT 059QF0KO0R EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3172 EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S INC.] 9 Current NDC, Legacy NDC, 4 package rows 20221213_9b18453e-e338-4b8e-9856-85aca8c46ee1.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 EARACHE DROPS BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR Hyland's Inc. 9b18453e-e338-4b8e-9856-85aca8c46ee1 2022-12-12 Warnings Exact identifier ndc (product): 54973-3172
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54973-3172-1 54973317201 1 BOTTLE, DROPPER in 1 CARTON (54973-3172-1) / 10 mL in 1 BOTTLE, DROPPER 2004-06-17 0000-00-00 No No Current 54973-3172-2 54973317202 1 BOTTLE, DROPPER in 1 CARTON (54973-3172-2) > 12 mL in 1 BOTTLE, DROPPER 2004-06-17 0000-00-00 No No Current