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Inflammation

Inflammation 2467L

Approved
Approval ID

9c1da6dd-5c6c-72c1-e053-2995a90a2f5a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 27, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-2467
Product Classification
G
Generic Name
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
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2025
FDA Product Classification

INGREDIENTS (27)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
BACILLUS ANTHRACIS IMMUNOSERUM RABBITActive
Quantity: 30 [hp_X] in 1 mL
Code: 41LZ22DD4N
Classification: ACTIB
ALOEActive
Quantity: 15 [hp_X] in 1 mL
Code: V5VD430YW9
Classification: ACTIB
RANCID BEEFActive
Quantity: 30 [hp_X] in 1 mL
Code: 29SUH5R3HU
Classification: ACTIB
ACONITUM NAPELLUSActive
Quantity: 15 [hp_X] in 1 mL
Code: U0NQ8555JD
Classification: ACTIB
APIS MELLIFERAActive
Quantity: 15 [hp_X] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ARNICA MONTANAActive
Quantity: 15 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 15 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
BAPTISIA TINCTORIA ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: 5EF0HWI5WU
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 15 [hp_X] in 1 mL
Code: WQZ3G9PF0H
Classification: ACTIB
LYTTA VESICATORIAActive
Quantity: 15 [hp_X] in 1 mL
Code: 3Q034RO3BT
Classification: ACTIB
IODINEActive
Quantity: 15 [hp_X] in 1 mL
Code: 9679TC07X4
Classification: ACTIB
CHELIDONIUM MAJUSActive
Quantity: 15 [hp_X] in 1 mL
Code: 7E889U5RNN
Classification: ACTIB
CROTALUS HORRIDUS HORRIDUS VENOMActive
Quantity: 15 [hp_X] in 1 mL
Code: YHA2XLJ956
Classification: ACTIB
FERROSOFERRIC PHOSPHATEActive
Quantity: 15 [hp_X] in 1 mL
Code: 91GQH8I5F7
Classification: ACTIB
GAULTHERIA PROCUMBENS TOPActive
Quantity: 15 [hp_X] in 1 mL
Code: 830295X963
Classification: ACTIB
CALCIUM SULFIDEActive
Quantity: 15 [hp_X] in 1 mL
Code: 1MBW07J51Q
Classification: ACTIB
LACHESIS MUTA VENOMActive
Quantity: 15 [hp_X] in 1 mL
Code: VSW71SS07I
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 15 [hp_X] in 1 mL
Code: 269XH13919
Classification: ACTIB
PHOSPHORUSActive
Quantity: 15 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
ANEMONE PULSATILLAActive
Quantity: 15 [hp_X] in 1 mL
Code: I76KB35JEV
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 15 [hp_X] in 1 mL
Code: 6IO182RP7A
Classification: ACTIB
VERATRUM VIRIDE ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: 197B3Q7T5Q
Classification: ACTIB
VERBASCUM THAPSUSActive
Quantity: 15 [hp_X] in 1 mL
Code: C9TD27U172
Classification: ACTIB
ECHINACEA, UNSPECIFIEDActive
Quantity: 6 [hp_X] in 1 mL
Code: 4N9P6CC1DX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2019

PACKAGE LABEL

package label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2019

INDICATIONS & USAGE SECTION

Formulated for symptoms such as pain, swelling, allergic reactions, congestion and joint problems.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2019

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 1/1/2019

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2019

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2019

OTC - PURPOSE SECTION

Formulated for symptoms such as pain, swelling, allergic reactions, congestion and joint problems..

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2019

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. Ifpregnant or breast-feeding, ask a doctor before use.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2019

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. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2019

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mellifica 6x, Echinacea 6x, Aconitum napellus 15x, Aloe 15x, Apis mellifica 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Crotalus horridus 15x, Ferrum phosphoricum 15x, Gaultheria procumbens 15x, Hepar sulphuris calcareum 15x, Iodium 15x, Lachesis mutus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Veratrum viride 15x, Verbascum thapsus 15x, Anthracinum 30x, Pyrogenium 30x.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2019

INACTIVE INGREDIENT SECTION

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

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Inflammation - FDA Drug Approval Details