FDA.reportPublic FDA data

Inflammation - Fever

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 02:04:56

Label at a glance#

ProductInflammation - Fever
Active ingredientBacillus Anthracis Immunoserum Rabbit, Rancid Beef, Aconitum Napellus, Aloe, Apis Mellifera, Arnica Montana, Arsenic Trioxide, Baptisia Tinctoria Root, Atropa Belladonna, Bryonia Alba Root, Lytta Vesicatoria, Chelidonium Majus, Crotalus Horridus Horridus Venom, Ferrosoferric Phosphate, Gaultheria Procumbens Top, Calcium Sulfide, Iodine, Lachesis Muta Venom, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Veratrum Viride Root, Verbascum Thapsus, Echinacea, Unspecified
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Inflammation - Fever  Formulated for symptoms associated with abscesses, ulcerations, cellulitis, sepsis, fever and other inflammatory and infectious processes.        

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Anthracinum 35x, Pyrogenium 35x, Aconitum nap. 20x, Aloe 20x, Apis mel. 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Belladonna 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Crotalus horridus 20x, Ferrum phosphoricum 20x, Gaultheria procumbens 20x, Hepar sulph. calc. 20x, Iodium 20x, Lachesis 20x, Nux vom. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Veratrum viride 20x, Verbascum 20x, Apis mel. 8x, Echinacea 8x, Apis mel. 3x, Echinacea 3x.                 

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with abscesses, ulcerations, cellulitis, sepsis, fever and other inflammatory and infectious processes.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.       

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

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

WARNINGS 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN 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
55714-4502-12020-01-31C16284748780-19d75b9d0-c28c-f424-e053-dadaa90a57ceInflammation - Fever
55714-4502-22020-01-31C16284748780-19d75b9d0-c28c-f424-e053-dadaa90a57ceInflammation - Fever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4502-1Inflammation - Fever29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-4502-2Inflammation - Fever59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4502INFLAMMATION - FEVER (ANTHRACINUM, PYROGENIUM, ACONITUM NAP., ALOE, APIS MEL., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, FERRUM PHOSPHORICUM, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, VERATRUM VIRIDE, VERBASCUM, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 2 package rows20130829_98c59b50-a696-54a6-514f-a8737e279022.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD2
AloeACTIVE INGREDIENTV5VD430YW92
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z2
Arnica MontanaACTIVE INGREDIENTO80TY208ZW2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Bacillus Anthracis Immunoserum RabbitACTIVE INGREDIENT41LZ22DD4N2
Baptisia Tinctoria RootACTIVE INGREDIENT5EF0HWI5WU2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q2
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN2
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9562
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Ferrosoferric PhosphateACTIVE INGREDIENT91GQH8I5F72
Gaultheria Procumbens TopACTIVE INGREDIENT830295X9632
IodineACTIVE INGREDIENT9679TC07X42
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Rancid BeefACTIVE INGREDIENT29SUH5R3HU2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Veratrum Viride RootACTIVE INGREDIENT197B3Q7T5Q2
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1722
Aconitum NapellusACTIVE MOIETYU0NQ8555JD2
AloeACTIVE MOIETYV5VD430YW92
Apis MelliferaACTIVE MOIETY7S82P3R43Z2
Arnica MontanaACTIVE MOIETYO80TY208ZW2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Bacillus Anthracis Immunoserum RabbitACTIVE MOIETY41LZ22DD4N2
Baptisia Tinctoria RootACTIVE MOIETY5EF0HWI5WU2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Calcium SulfideACTIVE MOIETY1MBW07J51Q2
Chelidonium MajusACTIVE MOIETY7E889U5RNN2
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9562
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Ferrosoferric PhosphateACTIVE MOIETY91GQH8I5F72
Gaultheria Procumbens TopACTIVE MOIETY830295X9632
IodineACTIVE MOIETY9679TC07X42
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT2
PhosphorusACTIVE MOIETY27YLU75U4W2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Rancid BeefACTIVE MOIETY29SUH5R3HU2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
Veratrum Viride RootACTIVE MOIETY197B3Q7T5Q2
Verbascum ThapsusACTIVE MOIETYC9TD27U1722
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
55714-450255714-4502-1, 55714-4502-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bacillus Anthracis Immunoserum Rabbit41LZ22DD4NACTIB
Rancid Beef29SUH5R3HUACTIB
Aconitum NapellusU0NQ8555JDACTIB
AloeV5VD430YW9ACTIB
Apis Mellifera7S82P3R43ZACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIB
Baptisia Tinctoria Root5EF0HWI5WUACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Chelidonium Majus7E889U5RNNACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Ferrosoferric Phosphate91GQH8I5F7ACTIB
Gaultheria Procumbens Top830295X963ACTIB
Calcium Sulfide1MBW07J51QACTIB
Iodine9679TC07X4ACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Veratrum Viride Root197B3Q7T5QACTIB
Verbascum ThapsusC9TD27U172ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
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
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 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 / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 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
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 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
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact 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
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 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
d1c00990-2c01-d86f-bd89-6c761056cfef98c59b50-a696-54a6-514f-a8737e2790222011-06-01WarningsExact identifier
spl id: d1c00990-2c01-d86f-bd89-6c761056cfef
spl set id: 98c59b50-a696-54a6-514f-a8737e279022

Reported adverse events (FAERS/openFDA)#

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