Childrens Earache Relief

Manufacturer
King Bio Inc.
Effective date
2012-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:44

Label at a glance#

ProductChildrens Earache Relief
Active ingredientACONITUM NAPELLUS, ONION, APIS MELLIFERA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAPSICUM, CAUSTICUM, MATRICARIA RECUTITA, SOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, POTASSIUM CHLORIDE, CALOMEL, MERCURIUS SOLUBILIS, PLANTAGO MAJOR, SILICON DIOXIDE
Label structure8 sections

Indications and uses

Uses for fast relief of earache symptoms: ear pain, inflammation, discharge, fever, congestion, sensitivity to noise, ringing, throbbing, buzzing, and humming. Reference image childrens earache.jpg

Dosage and administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed. Adult Dose 3 pump sprays Children 2-12 years 2 pump sprays Reference image childrens earache.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS: Aconitum napellus, Allium capa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, and Silicea.

Reference image childrens earache.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

Reference image childrens earache.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

Adult Dose 3 pump sprays

Children 2-12 years 2 pump sprays

Reference image childrens earache.jpg

Purpose

OTC - PURPOSE SECTION

Uses for fast relief of earache symptoms:

  • ear pain
  • inflammation
  • discharge
  • fever
  • congestion
  • sensitivity to noise
  • ringing
  • throbbing
  • buzzing
  • humming
Reference image childrens earache.jpg

Warnings

WARNINGS SECTION

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other: Tamper resistant for your protection. Use only if safety seal is intact.

Reference image childrens earache.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Reference image childrens earache.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for fast relief of earache symptoms: ear pain, inflammation, discharge, fever, congestion, sensitivity to noise, ringing, throbbing, buzzing, and humming.

Reference image childrens earache.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of labelImage of label


King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357955531524GTIN-13: 0357955531524
EAN-13: 0357955531524
GTIN-12: 357955531524
UPC-A: 357955531524
GTIN storage (14 digits): 00357955531524
childrens earache.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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
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
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5315-22020-01-31C16284748780-19d75b9d0-6b8f-f424-e053-dadaa90a57ceChildren's Earache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5315-2Childrens Earache Relief59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5315CHILDRENS EARACHE RELIEF (ACONITUM NAPELLUS, ALLIUM CAPA, APIS MELLIFICA, BELLADONNA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CAUSTICUM, CHAMOMILLA, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, MERCURIUS DULCIS, MERCURIUS SOLUBILIS, PLANTAGO MAJOR, AND SILICEA) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20120413_ad83dcf0-6354-426e-a8ec-1fa233051905.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q1
CALOMELACTIVE INGREDIENTJ2D46N657D1
CAPSICUMACTIVE INGREDIENT00UK7646FG1
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G21
ONIONACTIVE INGREDIENT492225Q21H1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I101
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162N1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CALOMELACTIVE MOIETYJ2D46N657D1
CAPSICUMACTIVE MOIETY00UK7646FG1
CAUSTICUMACTIVE MOIETYDD5FO1WKFU1
FERRIC CATIONACTIVE MOIETY91O4LML6111
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G21
ONIONACTIVE MOIETY492225Q21H1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162N1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-531557955-5315-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML · Source PDF

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
67af2571-6b32-4cb6-ac42-23973f94c88fad83dcf0-6354-426e-a8ec-1fa2330519052012-04-13WarningsExact identifier
spl id: 67af2571-6b32-4cb6-ac42-23973f94c88f
spl set id: ad83dcf0-6354-426e-a8ec-1fa233051905

Reported adverse events (FAERS/openFDA)#

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