FDA.reportPublic FDA data

ShinglePlex

Manufacturer
King Bio Inc.
Effective date
2016-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:33

Label at a glance#

ProductShinglePlex
Active ingredientARSENIC TRIOXIDE, CAPSICUM, MENTHA PIPERITA, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Arsenicum album, Capsicum annuum, Mentha piperita, Mezereum, Natrum muriaticum, Ranunculus bulbosus, Rhus toxicodendron. Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

INDICATIONS & USAGE SECTION

Uses for temporary relief of symptoms of Herpes zoster (shingles): itching, burning, painful irritations and vesicles.

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.

OTHER SAFETY INFORMATION

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

OTC - PURPOSE SECTION

Uses for temporary relief of symptoms of Herpes zoster (shingles):

  • itching
  • burning
  • painful irritations
  • vesicles.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5518-22020-01-31C16284748780-19d75b9cf-dafc-f424-e053-dadaa90a57ceShinglePlex™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5518-2ShinglePlex59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5518SHINGLEPLEX (ARSENICUM ALBUM, CAPSICUM ANNUUM, MENTHA PIPERITA, MEZEREUM, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, RHUS TOXICODENDRON) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20160318_21d754a3-0dca-4c7a-859e-3679f127506c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-551857955-5518-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
CAPSICUM00UK7646FGACTIB
MENTHA PIPERITA79M2M2UDA9ACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
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
ed7f9492-8fc2-47ed-a456-3a0f96aeec7b21d754a3-0dca-4c7a-859e-3679f127506c2016-03-18WarningsExact identifier
spl id: ed7f9492-8fc2-47ed-a456-3a0f96aeec7b
spl set id: 21d754a3-0dca-4c7a-859e-3679f127506c

Reported adverse events (FAERS/openFDA)#

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