FDA.reportPublic FDA data

TMJ / Jaw Formula

Manufacturer
King Bio Inc.
Effective date
2016-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:33

Label at a glance#

ProductTMJ / Jaw Formula
Active ingredientBAPTISIA TINCTORIA ROOT, CALCIUM FLUORIDE, CAUSTICUM, CALCIUM SULFIDE, HYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, KALMIA LATIFOLIA LEAF, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, COMFREY ROOT
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amara, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale. Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

INDICATIONS & USAGE SECTION

Uses ​for temporary relief of: facial pains of the jaw, facial neuralgia, rigid jaw muscles, inflammation in the jaw, clenching of the jaw, cracking sounds.​

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up: 3 sprays 3 times per day.
  • Ages 2-12: 2 sprays 3 times per day

OTHER SAFETY INFORMATION

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

OTC - PURPOSE SECTION

Uses ​for temporary relief of:

  • facial pains of the jaw
  • facial neuralgia
  • rigid jaw muscles
  • inflammation in the jaw
  • clenching of the jaw
  • cracking sounds

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5032-22020-01-31C16284748780-19d75b9d0-5e33-f424-e053-dadaa90a57ceTMJ / Jaw Formula™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5032-2TMJ / Jaw Formula59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5032TMJ / JAW FORMULA (BAPTISIA TINCTORIA, CALCAREA FLUORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, IGNATIA AMARA, KALMIA LATIFOLIA, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON SANGUINARIA CANADENSIS, SYMPHYTUM OFFICINALE) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20160321_228fe129-67c8-4003-97dd-801ec3fd8518.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-503257955-5032-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CAUSTICUMDD5FO1WKFUACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
KALMIA LATIFOLIA LEAF79N6542N18ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
COMFREY ROOTM9VVZ08EKQACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
ffbecae3-dbd5-4a51-a043-81502c499b9b228fe129-67c8-4003-97dd-801ec3fd85182016-03-21WarningsExact identifier
spl id: ffbecae3-dbd5-4a51-a043-81502c499b9b
spl set id: 228fe129-67c8-4003-97dd-801ec3fd8518

Reported adverse events (FAERS/openFDA)#

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