N-3

Product NDC
58264-0201
11-digit product format
582640201
Labeler code
58264
Product ID
58264-0201_2b538be3-baa6-3c2b-e063-6294a90a1489
Type
HUMAN OTC DRUG
Nonproprietary name
BERBERIS VULGARIS WHOLE, LYCOPODIUM CLAVATUM WHOLE, SMILAX ORNATA WHOLE, RUBIA TINCTORUM WHOLE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, and PORK KIDNEY
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
BERBERIS VULGARIS WHOLE; LYCOPODIUM CLAVATUM WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK KIDNEY; RUBIA TINCTORUM WHOLE; SMILAX ORNATA WHOLE
Active strength
4; 4; 30; 200; 4; 4 [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-3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS WHOLE4 [hp_X]/mL
LYCOPODIUM CLAVATUM WHOLE4 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]/mL
PORK KIDNEY200 [hp_X]/mL
RUBIA TINCTORUM WHOLE4 [hp_X]/mL
SMILAX ORNATA WHOLE4 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii492B79913J, 005ICF6L27, 2E32821G6I, X7BCI5P86H, DEF14459OH, SJO6NF5H81

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0201-12022-06-06C16284748780-19d75b9cf-e534-f424-e053-dadaa90a57ceN-3
58264-0201-12020-01-31C16284748780-19d75b9cf-e534-f424-e053-dadaa90a57ceN-3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0201-1N-329.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0201N-3 (BERBERIS VULGARIS WHOLE, LYCOPODIUM CLAVATUM WHOLE, SMILAX ORNATA WHOLE, RUBIA TINCTORUM WHOLE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND PORK KIDNEY) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_36e3a243-af04-416a-ac85-0a9962e872a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0201-15826402010129.57 mL in 1 BOTTLE, GLASS (58264-0201-1) 29.57 ml1990-01-010000-00-00NoNoCurrent