N-25

Product NDC
58264-0223
11-digit product format
582640223
Labeler code
58264
Product ID
58264-0223_2ce0d96c-0aaf-1b99-e063-6294a90a1456
Type
HUMAN OTC DRUG
Nonproprietary name
SERENOA REPENS WHOLE, AGATHOSMA CRENULATA WHOLE, Chimaphila umbellata, ELYMUS REPENS WHOLE, SELENIUM, and BOS TAURUS PROSTATE GLAND
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
AGATHOSMA CRENULATA WHOLE; BOS TAURUS PROSTATE GLAND; CHIMAPHILA UMBELLATA; ELYMUS REPENS WHOLE; SELENIUM; SERENOA REPENS WHOLE
Active strength
2; 200; 3; 3; 6; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
N-25
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AGATHOSMA CRENULATA WHOLE2 [hp_X]/mL
BOS TAURUS PROSTATE GLAND200 [hp_X]/mL
CHIMAPHILA UMBELLATA3 [hp_X]/mL
ELYMUS REPENS WHOLE3 [hp_X]/mL
SELENIUM6 [hp_X]/mL
SERENOA REPENS WHOLE2 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB6642J883V, 1P66FXU2MW, WCK21A9W9J, BE5076899X, H6241UJ22B, 487DXM62F2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0223-12022-06-06C16284748780-19d75b9d0-11f5-f424-e053-dadaa90a57ceN-25
58264-0223-12020-01-31C16284748780-19d75b9d0-11f5-f424-e053-dadaa90a57ceN-25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0223-1N-2529.57 mL in 1 BOTTLE, GLASSSOLUTION29.574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0223N-25 (SERENOA REPENS WHOLE, AGATHOSMA CRENULATA WHOLE, CHIMAPHILA UMBELLATA, ELYMUS REPENS WHOLE, SELENIUM, AND BOS TAURUS PROSTATE GLAND) SOLUTION [DNA LABS, INC.]4Current NDC, Legacy NDC, 1 package rows20250130_db4f1434-c26b-4526-95d1-00099bf77839.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0223-15826402230129.57 mL in 1 BOTTLE, GLASS (58264-0223-1) 29.57 ml1990-01-010000-00-00NoNoCurrent