Amalgam

Product NDC
63083-6003
11-digit product format
630836003
Labeler code
63083
Product ID
63083-6003_2372e62a-e3fe-46a4-9acc-2c9df499085e
Type
HUMAN OTC DRUG
Nonproprietary name
Amalgam
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
BOS TAURUS BONE; BOS TAURUS GINGIVA; EPICHLOROHYDRIN; FLUORINE; GOLD; ISATIS TINCTORIA ROOT; MERCURIUS SOLUBILIS; NICKEL; PALLADIUM; PLATINUM; SILICON DIOXIDE; SILVER; SODIUM FLUORIDE; TILLETIA CARIES; TITANIUM; TREPONEMA DENTICOLA; XANTHAN GUM; ZINC CATION
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amalgam
Brand name suffix
6003
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOS TAURUS BONE30 [hp_X]/59mL
BOS TAURUS GINGIVA30 [hp_X]/59mL
EPICHLOROHYDRIN30 [hp_X]/59mL
FLUORINE30 [hp_X]/59mL
GOLD30 [hp_X]/59mL
ISATIS TINCTORIA ROOT30 [hp_X]/59mL
MERCURIUS SOLUBILIS30 [hp_X]/59mL
NICKEL30 [hp_X]/59mL
PALLADIUM30 [hp_X]/59mL
PLATINUM30 [hp_X]/59mL
SILICON DIOXIDE30 [hp_X]/59mL
SILVER30 [hp_X]/59mL
SODIUM FLUORIDE30 [hp_X]/59mL
TILLETIA CARIES30 [hp_X]/59mL
TITANIUM30 [hp_X]/59mL
TREPONEMA DENTICOLA30 [hp_X]/59mL
XANTHAN GUM30 [hp_X]/59mL
ZINC CATION30 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTRS31EO6ZN, GJ2F3208WP, 08OOR508C0, 284SYP0193, 79Y1949PYO, 8S10GFI6DX, 324Y4038G2, 7OV03QG267, 5TWQ1V240M, 49DFR088MY, ETJ7Z6XBU4, 3M4G523W1G, 8ZYQ1474W7, C7000B9PQI, D1JT611TNE, 6TN2P16IOQ, TTV12P4NEE, 13S1S8SF37

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-6003AMALGAM 6003 (AMALGAM) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220405_1af74f69-a23a-45a2-a20e-92bf8b0ccb22.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-6003-26308360030259 mL in 1 BOTTLE, DROPPER (63083-6003-2) 59 ml1985-08-150000-00-00NoNoCurrent