FDA.reportPublic FDA data

Shingles

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:43:46

Label at a glance#

ProductShingles
Active ingredientMATRICARIA CHAMOMILLA, ASTERIAS RUBENS, LYTTA VESICATORIA, HELIANTHEMUM CANADENSE, CROTON TIGLIUM SEED, MUCUNA PRURIENS FRUIT TRICHOME, SOLANUM DULCAMARA TOP, GRAPHITE, GRINDELIA HIRSUTULA FLOWERING TOP, HYPERICUM PERFORATUM, IRIS VERSICOLOR ROOT, LYCOPODIUM CLAVATUM SPORE, DAPHNE MEZEREUM BARK, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, DELPHINIUM STAPHISAGRIA SEED, SULFUR, THUJA OCCIDENTALIS LEAFY TWIG, ZINC, APIS MELLIFERA, ECHINACEA, UNSPECIFIED, ARSENIC TRIOXIDE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated syptoms such as pain, burning, itching, swelling and skin eruptions.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Echinacea 6x, Apis mellifica 15x, Arsenicum album 15x, Asterias rubens 15x, Cantharis 15x, Cistus canadensis 15x, Croton tiglium 15x, Dolichos pruriens 15x, Dulcamara 15x, Graphites 15x, Grindelia 15x, Hypericum perforatum 15x, Iris versicolor 15x, Lycopodium clavatum 15x, Mezereum 15x, Ranunculus bulbosus 15x, Rhus toxicodendron 15x, Staphysagria 15x, Sulphur 15x, Thuja occidentalis 15x, Zincum metallicum 15x.

OTC - PURPOSE SECTION

Formulated for associated syptoms such as pain, burning, itching, swelling and skin eruptions.

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as need or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2515-12025-10-03C16284748780-12cef2736-65fa-d83d-e063-dadaa90ab31fShingles 2515P
55714-2515-12025-01-30C16284748780-12cef2736-65fa-d83d-e063-dadaa90ab31fShingles 2515P

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2515SHINGLES (CHAMOMILLA, ECHINACEA, APIS MELLIFICA, ARSENICUM ALBUM, ASTERIAS RUBENS, CANTHARIS, CISTUS CANADENSIS, CROTON TIGLIUM, DOLICHOS PRURIENS, DULCAMARA, GRAPHITES, GRINDELIA, HYPERICUM PERFORATUM, IRIS VERSICOLO, LYCOPODIUM CLAVATUM, MEZEREUM, RANUNCULUS BULBOSUS, RHUS TOXICODENDRON, STAPHYSAGRIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM) PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC20200123_9cbf2dca-de21-4841-e053-2a95a90a562c.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-251555714-2515-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
SUCROSEC151H8M554IACT
ASTERIAS RUBENSA7FYY9Q742ACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
MUCUNA PRURIENS FRUIT TRICHOME3E271BSI0CACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GRAPHITE4QQN74LH4OACTIB
GRINDELIA HIRSUTULA FLOWERING TOPIDB0NAZ6AIACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
SULFUR70FD1KFU70ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ZINCJ41CSQ7QDSACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB

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
40475104-5fcf-3fa6-e063-6394a90a48cc9cbf2dca-de21-4841-e053-2a95a90a562c2025-10-03WarningsExact identifier
spl set id: 9cbf2dca-de21-4841-e053-2a95a90a562c

Reported adverse events (FAERS/openFDA)#

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