FDA.reportPublic FDA data

Bact-In

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:44

Label at a glance#

ProductBact-In
Active ingredientECHINACEA, UNSPECIFIED, RANCID BEEF, URTICA URENS, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, GOLDENSEAL, IODINE, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT, IRIS VERSICOLOR ROOT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as fever, chills, fatigue, weakness and loss of appetite.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Iris versicolor 6x, Urtica urens 6x, Aconitum napellus 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bryonia 15x, Hydrastis canadensis 15x, Iodium 15x, Lachesis mutus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Anthracinum 30x, Pyrogenium 30x.

OTC - PURPOSE SECTION

Formulated for symptoms such as fever, chills, fatigue, weakness and loss of appetite.

INACTIVE INGREDIENT SECTION

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

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.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4836-1Bact-In30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4836BACT-IN (ECHINACEA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, URTICA URENS, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, HYDRASTIS CANADENSIS, IODIUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, ANTHRACINUM, PYROGENIUM) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201203_9a9f61c8-1913-1e6d-e053-2a95a90a8356.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-483655714-4836-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
RANCID BEEF29SUH5R3HUACTIB
URTICA URENSIHN2NQ5OF9ACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
GOLDENSEALZW3Z11D0JVACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB

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
Bact-InECHINACEA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, URTICA URENS, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, HYDRASTIS CANADENSIS, IODIUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, ANTHRACINUM, PYROGENIUMNewton Laboratories, Inc.9a9f61c8-1913-1e6d-e053-2a95a90a83562020-12-02WarningsExact identifier
ndc (package): 55714-4836-1
ndc (product): 55714-4836
ndc11 (package): 55714483601
spl id: b57f7b94-52ec-583c-e053-2995a90a8cbf
spl set id: 9a9f61c8-1913-1e6d-e053-2a95a90a8356

Reported adverse events (FAERS/openFDA)#

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