AM-9

Product NDC
58264-0348
11-digit product format
582640348
Labeler code
58264
Product ID
58264-0348_2b52e035-8802-a7f5-e063-6294a90ad8bd
Type
HUMAN OTC DRUG
Nonproprietary name
Spigelia anthelmia, Silicon dioxide, and Corallium rubrum whole
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
CORALLIUM RUBRUM WHOLE; SILICON DIOXIDE; SPIGELIA ANTHELMIA
Active strength
10; 8; 8 [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
AM-9
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CORALLIUM RUBRUM WHOLE10 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL
SPIGELIA ANTHELMIA8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii22Z32PWR7R, ETJ7Z6XBU4, WYT05213GE

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0348-12022-06-02C16284748780-19d75b9d1-199b-f424-e053-dadaa90a57ceAM-9
58264-0348-12020-01-31C16284748780-19d75b9d1-199b-f424-e053-dadaa90a57ceAM-9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0348-1AM-929.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0348AM-9 (SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_d7a00f0b-de4c-4bff-b8e0-86a82bed8bb9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0348-15826403480129.57 mL in 1 BOTTLE, GLASS (58264-0348-1) 29.57 ml1990-01-010000-00-00NoNoCurrent