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

Additional Listing Data#

Finished product
Yes
Brand name base
EARACHE DROPS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANEMONE PATENS WHOLE30 [hp_C]/mL
BELLADONNA LEAF30 [hp_C]/mL
CALCIUM CARBONATE30 [hp_C]/mL
CHAMOMILE30 [hp_C]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_C]/mL
SULFUR30 [hp_C]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4M1169RWJD, 6GZW20TIOI, H0G9379FGK, FGL3685T2X, C88X29Y479, 70FD1KFU70

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3172-1EARACHE DROPS1 in 1 CARTONLIQUID19
54973-3172-1EARACHE DROPS10 mL in 1 BOTTLE, DROPPERLIQUID109
54973-3172-2EARACHE DROPS1 in 1 CARTONLIQUID19
54973-3172-2EARACHE DROPS12 mL in 1 BOTTLE, DROPPERLIQUID129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3172-1ML - Milliliter54973-3172c48e7cfa-33fc-49b3-8983-ea0f97c979d512023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANEMONE PATENSACTIVE INGREDIENT4M1169RWJDEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
BELLADONNA LEAFACTIVE INGREDIENT6GZW20TIOIEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
CHAMOMILEACTIVE INGREDIENTFGL3685T2XEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
SULFURACTIVE INGREDIENT70FD1KFU70EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
ANEMONE PATENSACTIVE MOIETY4M1169RWJDEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
BELLADONNA LEAFACTIVE MOIETY6GZW20TIOIEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
CHAMOMILEACTIVE MOIETYFGL3685T2XEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
SULFURACTIVE MOIETY70FD1KFU70EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S]2
WATERINACTIVE INGREDIENT059QF0KO0REARACHE 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
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3172EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR) LIQUID [HYLAND'S INC.]9Current NDC, Legacy NDC, 4 package rows20221213_9b18453e-e338-4b8e-9856-85aca8c46ee1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3172-1549733172011 BOTTLE, DROPPER in 1 CARTON (54973-3172-1) / 10 mL in 1 BOTTLE, DROPPER2004-06-170000-00-00NoNoCurrent
54973-3172-2549733172021 BOTTLE, DROPPER in 1 CARTON (54973-3172-2) > 12 mL in 1 BOTTLE, DROPPER2004-06-170000-00-00NoNoCurrent