Helonias Combination

Product NDC
63083-9227
11-digit product format
630839227
Labeler code
63083
Product ID
63083-9227_365bca44-ba7b-4fa8-bc03-b1c2edf3ed7b
Type
HUMAN OTC DRUG
Nonproprietary name
Helonias Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
AMMONIUM BROMIDE; APIS MELLIFERA; BLACK COHOSH; CHAMAELIRIUM LUTEUM ROOT; CHLAMYDIA TRACHOMATIS; GOLD MONOIODIDE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MELILOTUS OFFICINALIS TOP; MERCURIC CHLORIDE; NAJA NAJA VENOM; PALLADIUM; PULSATILLA MONTANA WHOLE; VESPA CRABRO; VIBURNUM OPULUS BARK
Active strength
8; 4; 4; 6; 12; 12; 12; 4; 4; 4; 12; 12; 12; 4; 4; 2 [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Helonias Combination
Brand name suffix
9227
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMMONIUM BROMIDE8 [hp_X]/29.5mL
APIS MELLIFERA4 [hp_X]/29.5mL
BLACK COHOSH4 [hp_X]/29.5mL
CHAMAELIRIUM LUTEUM ROOT6 [hp_X]/29.5mL
CHLAMYDIA TRACHOMATIS12 [hp_X]/29.5mL
GOLD MONOIODIDE12 [hp_X]/29.5mL
LACHESIS MUTA VENOM12 [hp_X]/29.5mL
LILIUM LANCIFOLIUM WHOLE FLOWERING4 [hp_X]/29.5mL
LYCOPODIUM CLAVATUM SPORE4 [hp_X]/29.5mL
MELILOTUS OFFICINALIS TOP4 [hp_X]/29.5mL
MERCURIC CHLORIDE12 [hp_X]/29.5mL
NAJA NAJA VENOM12 [hp_X]/29.5mL
PALLADIUM12 [hp_X]/29.5mL
PULSATILLA MONTANA WHOLE4 [hp_X]/29.5mL
VESPA CRABRO4 [hp_X]/29.5mL
VIBURNUM OPULUS BARK2 [hp_X]/29.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR0JB3224WS, 7S82P3R43Z, K73E24S6X9, DQV54Y5H3U, T6NI39QU44, T1UDV7ES1A, VSW71SS07I, X67Z2963PI, C88X29Y479, GM6P02J2DX, 53GH7MZT1R, ZZ4AG7L7VM, 5TWQ1V240M, 24K790T39B, K3ALM8S49H, T1UG6H6805

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9227-12026-01-08C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227
63083-9227-12026-01-08C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227
63083-9227-12024-01-30C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227
63083-9227-12024-01-30C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9227-1Helonias Combination922729.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9227HELONIAS COMBINATION 9227 (HELONIAS COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220210_861f6d82-9bd8-4911-a751-9b93ae2210e9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9227-16308392270129.5 mL in 1 BOTTLE, DROPPER (63083-9227-1) 29.5 ml1985-08-150000-00-00NoNoCurrent