Baby Teething

Manufacturer
King Bio Inc
Effective date
2018-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:16

Label at a glance#

ProductBaby Teething
Active ingredientAMANITA MUSCARIA FRUITING BODY, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PHYTOLACCA AMERICANA ROOT, PODOPHYLLUM, RHEUM OFFICINALE ROOT, ZINC
Label structure9 sections

Indications and uses

for temporary relief of:  tething pain irritated gums delayed teething fever-like disturbances restlessness heavy salivation and drooling irritability desire to be held constantly

Dosage and administration

Initially, depress pump until primed. Spray one dose directly into mouth Under 3 months: Consult a licensed healthcare professional before using 3 months to 2 years: 1 spray every 15 minutes. up to 4 doses, then hourly until relieved 2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Agaicus muscarius, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Hepar sulphuris calcareum, Magnesia phosphorica, Phytolacca decandra, Podophyllum peltatum, Rheum, Zincum metallicum

Equal volumes of each in 30X, 60X, and 1LM potencies.

Purpose

OTC - PURPOSE SECTION

HPUS Ingredient:                                 Purpose:

Agaicus muscarius...............................irritated gums

Calcarea carbonica...............................sleeplessness, difficult, delayed teething

Calcarea fluorica..................................toothache, vomiting in infants, supports dental development

Calcarea phosphorica............................discomforts from teething

Chamomilla..........................................desire to be held constantly

Ferrum phosphoricum............................fever-like disturbaces

Hepar sulphuris calcareum......................overly sensitive

Magnesia phosphorica............................complaints of teething

Phytolacca decandra...............................excess saliva, teething children, clenched teeth

Podophyllum peltatum............................drooling, difficult dentition, fussiness, restlessness

Rheum.................................................increased saliva, difficult teething, restlessness, irritability

Zincum metallicum.................................difficult teething, irritability

Uses

INDICATIONS & USAGE SECTION

for temporary relief of: 

  • tething pain
  • irritated gums
  • delayed teething
  • fever-like disturbances
  • restlessness
  • heavy salivation and drooling
  • irritability
  • desire to be held constantly

Directions

DOSAGE & ADMINISTRATION SECTION

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth

Under 3 months: Consult a licensed healthcare professional before using

3 months to 2 years: 1 spray every 15 minutes. up to 4 doses, then hourly until relieved

2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

Warnings

WARNINGS SECTION

  • Stop use and ask a doctor, if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

Other Information

OTHER SAFETY INFORMATION

  • This product is intended to compliment, not replace, standard medical care.
  • Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bio-Energetically Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicer japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0467-22020-01-31C16284748780-19d75b9d0-69b2-f424-e053-dadaa90a57ceBaby Teething

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0467-2Baby Teething59 mL in 1 BOTTLE, SPRAYLIQUID591
57955-0467-2Baby Teething1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0467BABY TEETHING (AGAICUS MUSCARIUS, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, MAGNESIA PHOSPHORICA, PHYTOLACCA DECANDRA, PODOPHYLLUM PELTATUM, RHEUM, ZINCUM METALLICUM) LIQUID [KING BIO INC]1Legacy NDC, 2 package rows20180305_fbd2b2b3-a1e8-4f62-848e-e05b89b8ee47.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-046757955-0467-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
06d263cc-c43b-49a0-8cc5-2dd4840f2c6ffbd2b2b3-a1e8-4f62-848e-e05b89b8ee472018-03-05WarningsExact identifier
spl id: 06d263cc-c43b-49a0-8cc5-2dd4840f2c6f
spl set id: fbd2b2b3-a1e8-4f62-848e-e05b89b8ee47

Reported adverse events (FAERS/openFDA)#

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