FDA.reportPublic FDA data

Amalgam

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:49:44

Label at a glance#

ProductAmalgam 6003
Active ingredientTILLETIA CARIES, BOS TAURUS GINGIVA, BOS TAURUS BONE, TREPONEMA DENTICOLA, ISATIS TINCTORIA ROOT, SILVER, GOLD, SILICON DIOXIDE, EPICHLOROHYDRIN, FLUORINE, MERCURIUS SOLUBILIS, XANTHAN GUM, NICKEL, PALLADIUM, PLATINUM, ZINC CATION, SODIUM FLUORIDE, TITANIUM
Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Caries 30X, 60X
Gingivitis 30X, 60X
Osteomyelitis 30X, 60X
Periodontitis 30X, 60X
Root ostitis 30X, 60X
and all the following at 30X, 60X, 100X:
Amalgam
Dental gold
Dental plastics
Epoxies
Fluorine
Mercurius solubilis
Misc. binders
Nickel
Palladium
Platinum
Setting agents
Silver (6 types)
Sodium fluoride
Titanium

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of swollen, red, or tender gums, occasional bad breath, minor toothache, occasional headache, irritability, or fatigue due to sensitivity to or exposure to oral/dental materials.*

OTC - PURPOSE SECTION

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

WARNINGS SECTION

Consult a doctor if condition worsens or symptoms persist. Not intended for use by individuals with retained amalgams. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Amalgam

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-6003-22026-01-08C16284748780-11030e365-0899-111a-e063-dadaa90a10e2X3
63083-6003-22026-01-08C16284748780-11030e365-0899-111a-e063-dadaa90a10e2X3
63083-6003-22024-01-30C16284748780-11030e365-0899-111a-e063-dadaa90a10e2X3
63083-6003-22024-01-30C16284748780-11030e365-0899-111a-e063-dadaa90a10e2X3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-6003-2Amalgam600359 mL in 1 BOTTLE, DROPPERLIQUID592

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-600363083-6003-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
TILLETIA CARIESC7000B9PQIACTIB
BOS TAURUS GINGIVAGJ2F3208WPACTIB
BOS TAURUS BONETRS31EO6ZNACTIB
TREPONEMA DENTICOLA6TN2P16IOQACTIB
ISATIS TINCTORIA ROOT8S10GFI6DXACTIB
SILVER3M4G523W1GACTIB
GOLD79Y1949PYOACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
EPICHLOROHYDRIN08OOR508C0ACTIB
FLUORINE284SYP0193ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
XANTHAN GUMTTV12P4NEEACTIB
NICKEL7OV03QG267ACTIB
PALLADIUM5TWQ1V240MACTIB
PLATINUM49DFR088MYACTIB
ZINC CATION13S1S8SF37ACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIB
TITANIUMD1JT611TNEACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:17:13

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
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
ndc (package): 63083-6003-2
ndc (product): 63083-6003
ndc11 (package): 63083600302
spl id: 2372e62a-e3fe-46a4-9acc-2c9df499085e
spl set id: 1af74f69-a23a-45a2-a20e-92bf8b0ccb22

Reported adverse events (FAERS/openFDA)#

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