Pyrogenium

Manufacturer: Newton Laboratories, Inc.
Effective date: 2020-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:14:01

Label at a glance#

ProductPyrogenium

Active ingredientRANCID BEEF

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Fevers; Offensive discharges; Infected wounds

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

Pyrogenium 200c, Pyrogenium 30c

OTC - PURPOSE SECTION

Fevers; Offensive discharges; Infected wounds

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? 1.800.448.7256

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 label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-6444-1	2022-01-28	C162847	48780-1	d6a99b39-671d-a426-e053-dadaa90af4c2	Pyrogenium 6444L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-6444-1	Pyrogenium	30 mL in 1 BOTTLE, GLASS	LIQUID	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-6444	PYROGENIUM LIQUID [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 1 package rows	20201218_b6ad16e5-1e23-81d1-e053-2995a90a4424.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Pyrogenium
ALCOHOL
WATER
RANCID BEEF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-6444	55714-6444-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT
RANCID BEEF	29SUH5R3HU	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b6ad01b0-35dd-224c-e053-2995a90ab64a			b6ad16e5-1e23-81d1-e053-2995a90a4424	2020-12-17	Warnings	Exact identifier spl id: b6ad01b0-35dd-224c-e053-2995a90ab64a spl set id: b6ad16e5-1e23-81d1-e053-2995a90a4424

Reported adverse events (FAERS/openFDA)#

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