FDA.reportPublic FDA data

Inflamma-Tone

Product NDC
64578-0083
11-digit product format
645780083
Labeler code
64578
Product ID
64578-0083_462bcce9-99ac-5fbc-e063-6294a90a61e6
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum Napellus, Belladonna, Bryonia (Alba), Chamomilla
Dosage form
LIQUID
Route
ORAL
Labeler
Energetix Corporation
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-10-03
Substance
ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA
Active strength
8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Inflamma-Tone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS8 [hp_X]/mL
ATROPA BELLADONNA8 [hp_X]/mL
BRYONIA ALBA ROOT8 [hp_X]/mL
MATRICARIA RECUTITA8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
T7J046YI2BInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2dfc3e14-5b3e-4a9a-bdbb-97bae3e46150Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64578-0083-1Inflamma-Tone59.1 mL in 1 BOTTLE, DROPPERLIQUID59.113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RINFLAMMA-TONE (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64578-0083INFLAMMA-TONE (ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), CHAMOMILLA) LIQUID [ENERGETIX CORPORATION]12Current NDC, Legacy NDC, 1 package rows20241215_2dfc3e14-5b3e-4a9a-bdbb-97bae3e46150.zip

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
Inflamma-ToneACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), CHAMOMILLAEnergetix Corporation2dfc3e14-5b3e-4a9a-bdbb-97bae3e461502025-12-17WarningsExact identifier
ndc (product): 64578-0083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64578-0083-16457800830159.1 mL in 1 BOTTLE, DROPPER (64578-0083-1) 59.1 ml2016-12-010000-00-00NoNoCurrent