N-8

Product NDC
58264-0206
11-digit product format
582640206
Labeler code
58264
Product ID
58264-0206_2b535a39-0bac-b8c0-e063-6394a90a80d3
Type
HUMAN OTC DRUG
Nonproprietary name
SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, and BOS TAURUS OVARY
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
SILICON DIOXIDE; ATROPA BELLADONNA; CITRULLUS COLOCYNTHIS FRUIT PULP; BLACK COHOSH; ANEMONE PULSATILLA; SEPIA OFFICINALIS JUICE; PALLADIUM; APIS MELLIFERA; BOS TAURUS OVARY
Active strength
6; 6; 6; 6; 6; 10; 10; 6; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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
2026-12-31
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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58264-0206-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0206-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0206-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0206-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0206-19bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
N-8
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILICON DIOXIDE6 [hp_X]/mL
ATROPA BELLADONNA6 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]/mL
BLACK COHOSH6 [hp_X]/mL
ANEMONE PULSATILLA6 [hp_X]/mL
SEPIA OFFICINALIS JUICE10 [hp_X]/mL
PALLADIUM10 [hp_X]/mL
APIS MELLIFERA6 [hp_X]/mL
BOS TAURUS OVARY200 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ETJ7Z6XBU4Internal UNII lookup
WQZ3G9PF0HInternal UNII lookup
23H32AOH17Internal UNII lookup
K73E24S6X9Internal UNII lookup
I76KB35JEVInternal UNII lookup
QDL83WN8C2Internal UNII lookup
5TWQ1V240MInternal UNII lookup
7S82P3R43ZInternal UNII lookup
66LZN1C747Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c25cdcb5-9469-48bb-b216-0a9d8d644e12Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0206-12022-06-06C16284748780-19d75b9d0-c172-f424-e053-dadaa90a57ceN-8
58264-0206-12020-01-31C16284748780-19d75b9d0-c172-f424-e053-dadaa90a57ceN-8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0206-1N-829.57 mL in 1 BOTTLE, GLASSSOLUTION29.574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0206N-8 (SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARY) SOLUTION [DNA LABS, INC.]4Current NDC, Legacy NDC, 1 package rows20250112_c25cdcb5-9469-48bb-b216-0a9d8d644e12.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
N-8SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARYDNA Labs, Inc.c25cdcb5-9469-48bb-b216-0a9d8d644e122025-01-09WarningsExact identifier
ndc (product): 58264-0206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0206-15826402060129.57 mL in 1 BOTTLE, GLASS (58264-0206-1) 29.57 ml1990-01-010000-00-00NoNoCurrent