FDA.reportPublic FDA data

Viral Infection

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:58

Label at a glance#

ProductViral Infection
Active ingredientInfluenza A Virus, Influenza B Virus, Measles Virus, Aconitum Napellus, Antimony Potassium Tartrate, Arnica Montana, Arsenic Trioxide, Baptisia Tinctoria Root, Atropa Belladonna, Bryonia Alba Root, Lytta Vesicatoria, Matricaria Recutita, Gaultheria Procumbens Top, Calcium Sulfide, Iodine, Lachesis Muta Venom, Lycopodium Clavatum Spore, Mercury, Phosphorus, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Trifolium Pratense Flower, Echinacea, Unspecified, Goldenseal
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

ABUSE SECTION

Viral Infection  Formulated for symptoms associated with mumps, tuberculosis, whooping cough, influenza, measles and other viral infections.

DOSAGE & ADMINISTRATION SECTION

ABUSE SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

ABUSE SECTION

Influenzinum 30x, Morbillinum 30x, Aconitum nap. 15x, Antimon. tart. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chamomilla 15x, Gaultheria procumbens 15x, Hepar sulph. calc.15x, Iodium 15x, Lachesis 15x, Lycopodium 15x, Merc. viv. 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Trifolium pratense 15x, Echinacea 3x, Hydrastis 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with mumps, tuberculosis, whooping cough, influenza, measles and other viral infections.

INACTIVE INGREDIENT SECTION

ABUSE SECTION

USP Purified water; USP Gluten-free, non-GMO, organic cane dispending alcohol 20%.

QUESTIONS? SECTION

ABUSE SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256

WARNINGS SECTION

ABUSE SECTION

Warning:  Do not use if tamper - evident seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children.

PREGNANCY OR BREAST FEEDING SECTION

ABUSE SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

KEEP OUT OF REACH OF CHILDREN SECTION

ABUSE SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4554-12020-01-31C16284748780-19d75b9d1-073b-f424-e053-dadaa90a57ceViral Infection
55714-4554-22020-01-31C16284748780-19d75b9d1-073b-f424-e053-dadaa90a57ceViral Infection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4554-1Viral Infection29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-4554-2Viral Infection59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4554VIRAL INFECTION (INFLUENZA A VIRUS, INFLUENZA B VIRUS, MORBILLINUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, LYCOPODIUM, MERC.VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, TRIFOLIUM PRATENSE, ECHINACEA, HYDRASTIS) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 2 package rows20130912_8962e3dd-f58d-abfb-2fd5-57b59cabf2d4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD2
Antimony Potassium TartrateACTIVE INGREDIENTDL6OZ476V32
Arnica MontanaACTIVE INGREDIENTO80TY208ZW2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Baptisia Tinctoria RootACTIVE INGREDIENT5EF0HWI5WU2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Gaultheria Procumbens TopACTIVE INGREDIENT830295X9632
GoldensealACTIVE INGREDIENTZW3Z11D0JV2
Influenza A VirusACTIVE INGREDIENTR9HH0NDE2E2
Influenza B VirusACTIVE INGREDIENT1314JZ2X6W2
IodineACTIVE INGREDIENT9679TC07X42
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT2
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ2
Measles VirusACTIVE INGREDIENTHT3R7C012Q2
MercuryACTIVE INGREDIENTFXS1BY2PGL2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Trifolium Pratense FlowerACTIVE INGREDIENT4JS08388282
Aconitum NapellusACTIVE MOIETYU0NQ8555JD2
Antimony Cation (3+)ACTIVE MOIETY069647RPT52
Arnica MontanaACTIVE MOIETYO80TY208ZW2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Baptisia Tinctoria RootACTIVE MOIETY5EF0HWI5WU2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Calcium SulfideACTIVE MOIETY1MBW07J51Q2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Gaultheria Procumbens TopACTIVE MOIETY830295X9632
GoldensealACTIVE MOIETYZW3Z11D0JV2
Influenza A VirusACTIVE MOIETYR9HH0NDE2E2
Influenza B VirusACTIVE MOIETY1314JZ2X6W2
IodineACTIVE MOIETY9679TC07X42
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT2
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ2
Measles VirusACTIVE MOIETYHT3R7C012Q2
MercuryACTIVE MOIETYFXS1BY2PGL2
PhosphorusACTIVE MOIETY27YLU75U4W2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
Trifolium Pratense FlowerACTIVE MOIETY4JS08388282
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-455455714-4554-1, 55714-4554-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
Influenza A VirusR9HH0NDE2EACTIB
Influenza B Virus1314JZ2X6WACTIB
Measles VirusHT3R7C012QACTIB
Aconitum NapellusU0NQ8555JDACTIB
Antimony Potassium TartrateDL6OZ476V3ACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIB
Baptisia Tinctoria Root5EF0HWI5WUACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Gaultheria Procumbens Top830295X963ACTIB
Calcium Sulfide1MBW07J51QACTIB
Iodine9679TC07X4ACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
MercuryFXS1BY2PGLACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Trifolium Pratense Flower4JS0838828ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
GoldensealZW3Z11D0JVACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
d3741ef3-2b18-2815-94a8-853f7aa3a8e68962e3dd-f58d-abfb-2fd5-57b59cabf2d42011-06-01Exact identifier
spl id: d3741ef3-2b18-2815-94a8-853f7aa3a8e6
spl set id: 8962e3dd-f58d-abfb-2fd5-57b59cabf2d4

Reported adverse events (FAERS/openFDA)#

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