Earache Remedy

Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:36:08

Label at a glance#

ProductEarache Remedy
Active ingredientACONITUM NAPELLUS, ATROPA BELLADONNA, POTASSIUM CHLORIDE, PLANTAGO MAJOR, MATRICARIA RECUTITA, VERBASCUM THAPSUS
Label structure8 sections

Label contents#

Full prescribing information#

Earache Remedy

OTC - ACTIVE INGREDIENT SECTION


Aconitum napellus 6X

Belladonna 3X

Chamomilla 6X

Kali mur 3X

Plantago major 3X

Verbascum 6X

Earache Remedy

INACTIVE INGREDIENT SECTION

Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water

Earache Remedy

WARNINGS SECTION

Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing seek the advice of your health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accedental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but this is not intended for internal use.

Earache Remedy

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children.

Earache Remedy

INDICATIONS & USAGE SECTION

A homeopathic combination for the temporary relief or earaches, inflammation of the external and internal ear. For the temporary relief of earches from congestion or swelling of middle ear or eustacian tubes.

DOSAGE & ADMINISTRATION SECTION

Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.

Earache Remedy

OTC - PURPOSE SECTION

Aconitum napellus - relieves earache, hot, painful, swollen ear.

Belladonna - relieves Otitis media, throbbing deep ear pain.

Chamomilla - relieves eache, soreness, swelling, otalgia.

Kali mur - relieves chronic catarrahal conditions of middle ear.

Plantago major - relieves earache, neuralgic earache, otalgia.

Verbascum - relieves catarrhs, otalgia with sense of obstruction.

Earache Remedy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelCartonCarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130019277000439GTIN-13: 0019277000439
EAN-13: 0019277000439
GTIN-12: 019277000439
UPC-A: 019277000439
GTIN storage (14 digits): 00019277000439
Earache Remedy Full Image Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-045-01Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID1510
64616-045-02Earache Remedy1 in 1 CARTONLIQUID110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H2
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I102
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U1722
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U2
POTASSIUM CATIONACTIVE MOIETY295O53K1522
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U1722
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y72
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH472
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-04564616-045-01, 64616-045-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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
Earache RemedyEAR DROPSVitality Works, Inc.49afb2c3-ee42-4be9-943a-36d73ded00042025-12-17WarningsExact identifier
ndc (package): 64616-045-02
ndc (package): 64616-045-01
ndc (product): 64616-045
ndc11 (package): 64616004501
ndc11 (package): 64616004502
spl id: 462f5699-1583-e885-e063-6394a90abbc6
spl set id: 49afb2c3-ee42-4be9-943a-36d73ded0004

Reported adverse events (FAERS/openFDA)#

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