FDA.reportPublic FDA data

HCB-Tone

Product NDC
64616-094
11-digit product format
646160094
Labeler code
64616
Product ID
64616-094_462ef9ee-890c-6eba-e063-6394a90a593b
Type
HUMAN OTC DRUG
Nonproprietary name
Heart Muscle Aid
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-04-04
Substance
CAMPHOR (NATURAL); GALIUM APARINE; HELODERMA HORRIDUM VENOM; KEROSENE; MARSDENIA CONDURANGO BARK; PAPAYA SEED; SALIX NIGRA BARK; SEMECARPUS ANACARDIUM JUICE; VERATRUM VIRIDE ROOT; VERBENA OFFICINALIS
Active strength
9; 10; 15; 15; 4; 8; 10; 6; 10; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [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
HCB-Tone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)9 [hp_X]/mL
GALIUM APARINE10 [hp_X]/mL
HELODERMA HORRIDUM VENOM15 [hp_X]/mL
KEROSENE15 [hp_X]/mL
MARSDENIA CONDURANGO BARK4 [hp_X]/mL
PAPAYA SEED8 [hp_C]/mL
SALIX NIGRA BARK10 [hp_X]/mL
SEMECARPUS ANACARDIUM JUICE6 [hp_X]/mL
VERATRUM VIRIDE ROOT10 [hp_X]/mL
VERBENA OFFICINALIS7 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN20HL7Q941, Z4B6561488, O9M1UQ4YIO, 1C89KKC04E, 2ZN3FO349A, QU52J3A5B3, Y0F0BU8RDU, 197B3Q7T5Q, QT8A71T9BM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-094-02HCB-Tone59 mL in 1 BOTTLE, DROPPERLIQUID598

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941HCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
GALIUM APARINEACTIVE INGREDIENTZ4B6561488HCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
HELODERMA HORRIDUM VENOMACTIVE INGREDIENTO9M1UQ4YIOHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
KEROSENEACTIVE INGREDIENT1C89KKC04EHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
MARSDENIA CONDURANGO BARKACTIVE INGREDIENTR23QIR6YBAHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
PAPAYA SEEDACTIVE INGREDIENT2ZN3FO349AHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
SALIX NIGRA BARKACTIVE INGREDIENTQU52J3A5B3HCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
SEMECARPUS ANACARDIUM JUICEACTIVE INGREDIENTY0F0BU8RDUHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
VERATRUM VIRIDE ROOTACTIVE INGREDIENT197B3Q7T5QHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
VERBENA OFFICINALISACTIVE INGREDIENTQT8A71T9BMHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941HCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
GALIUM APARINEACTIVE MOIETYZ4B6561488HCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
HELODERMA HORRIDUM VENOMACTIVE MOIETYO9M1UQ4YIOHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
KEROSENEACTIVE MOIETY1C89KKC04EHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
MARSDENIA CONDURANGO BARKACTIVE MOIETYR23QIR6YBAHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
PAPAYA SEEDACTIVE MOIETY2ZN3FO349AHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
SALIX NIGRA BARKACTIVE MOIETYQU52J3A5B3HCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
SEMECARPUS ANACARDIUM JUICEACTIVE MOIETYY0F0BU8RDUHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
VERATRUM VIRIDE ROOTACTIVE MOIETY197B3Q7T5QHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
VERBENA OFFICINALISACTIVE MOIETYQT8A71T9BMHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-094HCB-TONE (HEART MUSCLE AID) LIQUID [VITALITY WORKS, INC.]7Current NDC, Legacy NDC, 1 package rows20241212_0ca57b53-3f56-4795-a42b-d1b9f8237eb6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-094-026461600940259 mL in 1 BOTTLE, DROPPER (64616-094-02) 59 ml2013-04-040000-00-00NoNoCurrent