FDA.reportPublic FDA data

Hylands Naturals Earache Drops

Product NDC
54973-4124
Requested package NDC
54973-4124-1
11-digit product format
549734124
Labeler code
54973
Product ID
54973-4124_59d42624-de71-d5fa-e063-6394a90a7363
Type
HUMAN OTC DRUG
Nonproprietary name
belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-07-27
Substance
CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PATENS WHOLE; SULFUR; CALCIUM CARBONATE; BELLADONNA LEAF
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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hylands Naturals Earache Drops
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FGL3685T2XInternal UNII lookup
C88X29Y479Internal UNII lookup
4M1169RWJDInternal UNII lookup
70FD1KFU70Internal UNII lookup
H0G9379FGKInternal UNII lookup
6GZW20TIOIInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
017ed754-9fe8-2cb5-e063-6294a90ab2f6Available on FDA.report

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
54973-4124-1Hylands Naturals Earache Drops10 mL in 1 BOTTLE, DROPPERLIQUID106
54973-4124-1Hylands Naturals Earache Drops1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4124HYLANDS NATURALS EARACHE DROPS (BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR) LIQUID [HYLAND'S INC.]3Current NDC, 2 package rows20250524_017ed754-9fe8-2cb5-e063-6294a90ab2f6.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
ndc (package): 54973-4124-1
ndc (product): 54973-4124
ndc11 (package): 54973412401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
54973-4124-1549734124011 BOTTLE, DROPPER in 1 CARTON (54973-4124-1) / 10 mL in 1 BOTTLE, DROPPER2023-07-27NoNoCurrent