Helonias Combination

Product NDC
63083-9227
Requested package NDC
63083-9227-1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
VIBURNUM OPULUS BARK8 [hp_X]/29.5mL
APIS MELLIFERA4 [hp_X]/29.5mL
BLACK COHOSH4 [hp_X]/29.5mL
LILIUM LANCIFOLIUM WHOLE FLOWERING6 [hp_X]/29.5mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/29.5mL
MELILOTUS OFFICINALIS TOP12 [hp_X]/29.5mL
PULSATILLA MONTANA WHOLE12 [hp_X]/29.5mL
VESPA CRABRO4 [hp_X]/29.5mL
CHAMAELIRIUM LUTEUM ROOT4 [hp_X]/29.5mL
AMMONIUM BROMIDE4 [hp_X]/29.5mL
GOLD MONOIODIDE12 [hp_X]/29.5mL
CHLAMYDIA TRACHOMATIS12 [hp_X]/29.5mL
LACHESIS MUTA VENOM12 [hp_X]/29.5mL
MERCURIC CHLORIDE4 [hp_X]/29.5mL
NAJA NAJA VENOM4 [hp_X]/29.5mL
PALLADIUM2 [hp_X]/29.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T1UG6H6805Internal UNII lookup
7S82P3R43ZInternal UNII lookup
K73E24S6X9Internal UNII lookup
X67Z2963PIInternal UNII lookup
C88X29Y479Internal UNII lookup
GM6P02J2DXInternal UNII lookup
24K790T39BInternal UNII lookup
K3ALM8S49HInternal UNII lookup
DQV54Y5H3UInternal UNII lookup
R0JB3224WSInternal UNII lookup
T1UDV7ES1AInternal UNII lookup
T6NI39QU44Internal UNII lookup
VSW71SS07IInternal UNII lookup
53GH7MZT1RInternal UNII lookup
ZZ4AG7L7VMInternal UNII lookup
5TWQ1V240MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
861f6d82-9bd8-4911-a751-9b93ae2210e9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2026-01-08R227
2026-01-08R227
2024-01-30R227
2024-01-30R227

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

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
Helonias Combination 9227HELONIAS COMBINATIONProfessional Complementary Health Formulas861f6d82-9bd8-4911-a751-9b93ae2210e92026-01-08WarningsExact identifier
ndc (package): 63083-9227-1
ndc (product): 63083-9227
ndc11 (package): 63083922701

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