N-7

Product NDC
58264-0205
11-digit product format
582640205
Labeler code
58264
Product ID
58264-0205_2b53985a-2334-fd8d-e063-6294a90a8bbc
Type
HUMAN OTC DRUG
Nonproprietary name
Apis mellifera, Clematis recta whole, Anemone Pulsatilla, Chimaphila umbellata, Sus scrofa testicle, Chaste Tree, and Sepia Officinalis juice
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
APIS MELLIFERA; CLEMATIS RECTA WHOLE; ANEMONE PULSATILLA; CHIMAPHILA UMBELLATA; SUS SCROFA TESTICLE; CHASTE TREE; SEPIA OFFICINALIS JUICE
Active strength
6; 4; 5; 4; 200; 4; 10 [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 packagepackage58264-0205-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0205-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0205-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0205-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0205-19bebd1f3094a…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-7
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA6 [hp_X]/mL
CLEMATIS RECTA WHOLE4 [hp_X]/mL
ANEMONE PULSATILLA5 [hp_X]/mL
CHIMAPHILA UMBELLATA4 [hp_X]/mL
SUS SCROFA TESTICLE200 [hp_X]/mL
CHASTE TREE4 [hp_X]/mL
SEPIA OFFICINALIS JUICE10 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S82P3R43ZInternal UNII lookup
8L28IWF365Internal UNII lookup
I76KB35JEVInternal UNII lookup
WCK21A9W9JInternal UNII lookup
KM02613O28Internal UNII lookup
433OSF3U8AInternal UNII lookup
QDL83WN8C2Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ebe3a62-8f35-4cbe-815a-77e91c14f247Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0205-12022-06-06C16284748780-19d75b9d0-c16f-f424-e053-dadaa90a57ceN-7
58264-0205-12020-01-31C16284748780-19d75b9d0-c16f-f424-e053-dadaa90a57ceN-7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0205-1N-729.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0205N-7 (APIS MELLIFERA, CLEMATIS RECTA WHOLE, ANEMONE PULSATILLA, CHIMAPHILA UMBELLATA, SUS SCROFA TESTICLE, CHASTE TREE, AND SEPIA OFFICINALIS JUICE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_7ebe3a62-8f35-4cbe-815a-77e91c14f247.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-7APIS MELLIFERA, CLEMATIS RECTA WHOLE, ANEMONE PULSATILLA, CHIMAPHILA UMBELLATA, SUS SCROFA TESTICLE, CHASTE TREE, AND SEPIA OFFICINALIS JUICEDNA Labs, Inc.7ebe3a62-8f35-4cbe-815a-77e91c14f2472025-01-09WarningsExact identifier
ndc (product): 58264-0205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0205-15826402050129.57 mL in 1 BOTTLE, GLASS (58264-0205-1) 29.57 ml1990-01-010000-00-00NoNoCurrent