N-27

Product NDC
58264-0225
11-digit product format
582640225
Labeler code
58264
Product ID
58264-0225_2b53a874-d433-1d77-e063-6294a90a5f9d
Type
HUMAN OTC DRUG
Nonproprietary name
arnica montana, milk thistle, sus scrofa cerebrum, cinchona officinalis bark, ginkgo biloba whole, lecithin, soybean, lithium carbonate, achillea millefolium, phosphoric acid, pork brain, alnus glutinosa whole, and rosmarinus officinalis flowering top
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ACHILLEA MILLEFOLIUM; ALNUS GLUTINOSA WHOLE; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; GINKGO BILOBA WHOLE; LECITHIN, SOYBEAN; LITHIUM CARBONATE; MILK THISTLE; PHOSPHORIC ACID; PORK BRAIN; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA CEREBRUM
Active strength
3; 1; 3; 6; 6; 12; 30; 3; 30; 200; 1; 6 [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Mood Stabilizer [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 packagepackage58264-0225-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0225-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0225-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0225-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0225-19bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
N-27
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA3 [hp_X]/mL
MILK THISTLE1 [hp_X]/mL
SUS SCROFA CEREBRUM3 [hp_X]/mL
CINCHONA OFFICINALIS BARK6 [hp_X]/mL
GINKGO BILOBA WHOLE6 [hp_X]/mL
LECITHIN, SOYBEAN12 [hp_X]/mL
LITHIUM CARBONATE30 [hp_X]/mL
ACHILLEA MILLEFOLIUM3 [hp_X]/mL
PHOSPHORIC ACID30 [hp_X]/mL
PORK BRAIN200 [hp_X]/mL
ALNUS GLUTINOSA WHOLE1 [hp_X]/mL
ROSMARINUS OFFICINALIS FLOWERING TOP6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup
U946SH95EEInternal UNII lookup
4GB5DQR532Internal UNII lookup
S003A158SBInternal UNII lookup
660486U6OIInternal UNII lookup
1DI56QDM62Internal UNII lookup
2BMD2GNA4VInternal UNII lookup
2FXJ6SW4PKInternal UNII lookup
E4GA8884NNInternal UNII lookup
466251J72GInternal UNII lookup
0P5G9CD0Z7Internal UNII lookup
8JM482TI79Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df2d7683-3b45-4ddb-9b67-7bb74dad2854Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0225-12022-06-06C16284748780-19d75b9d0-10a2-f424-e053-dadaa90a57ceN-27
58264-0225-12020-01-31C16284748780-19d75b9d0-10a2-f424-e053-dadaa90a57ceN-27

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0225-1N-2729.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0225N-27 (ARNICA MONTANA, MILK THISTLE, SUS SCROFA CEREBRUM, CINCHONA OFFICINALIS BARK, GINKGO BILOBA WHOLE, LECITHIN, SOYBEAN, LITHIUM CARBONATE, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, PORK BRAIN, ALNUS GLUTINOSA WHOLE, AND ROSMARINUS OFFICINALIS FLOWERING TOP) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_df2d7683-3b45-4ddb-9b67-7bb74dad2854.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-27ARNICA MONTANA, MILK THISTLE, SUS SCROFA CEREBRUM, CINCHONA OFFICINALIS BARK, GINKGO BILOBA WHOLE, LECITHIN, SOYBEAN, LITHIUM CARBONATE, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, PORK BRAIN, ALNUS GLUTINOSA WHOLE, AND ROSMARINUS OFFICINALIS FLOWERING TOPDNA Labs, Inc.df2d7683-3b45-4ddb-9b67-7bb74dad28542025-01-09WarningsExact identifier
ndc (product): 58264-0225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0225-15826402250129.57 mL in 1 BOTTLE, GLASS (58264-0225-1) 29.57 ml1990-01-010000-00-00NoNoCurrent