FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACHILLEA MILLEFOLIUM3 [hp_X]/mL
ALNUS GLUTINOSA WHOLE1 [hp_X]/mL
ARNICA MONTANA3 [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
MILK THISTLE3 [hp_X]/mL
PHOSPHORIC ACID30 [hp_X]/mL
PORK BRAIN200 [hp_X]/mL
ROSMARINUS OFFICINALIS FLOWERING TOP1 [hp_X]/mL
SUS SCROFA CEREBRUM6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FXJ6SW4PK, 0P5G9CD0Z7, O80TY208ZW, S003A158SB, 660486U6OI, 1DI56QDM62, 2BMD2GNA4V, U946SH95EE, E4GA8884NN, 466251J72G, 8JM482TI79, 4GB5DQR532

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

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