FDA.reportPublic FDA data

AM-10

Product NDC
58264-0349
11-digit product format
582640349
Labeler code
58264
Product ID
58264-0349_2b52e035-8801-a7f5-e063-6294a90ad8bd
Type
HUMAN OTC DRUG
Nonproprietary name
Nerium oleander leaf, Tribasic calcium phosphate, and Carbo animalis
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
CARBO ANIMALIS; NERIUM OLEANDER LEAF; TRIBASIC CALCIUM PHOSPHATE
Active strength
10; 12; 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-10
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NERIUM OLEANDER LEAF10 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/mL
CARBO ANIMALIS8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7KV510R6H6, 91D9GV0Z28, 279O8I0433

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0349-12022-06-02C16284748780-19d75b9d1-01a1-f424-e053-dadaa90a57ceAM-10
58264-0349-12020-01-31C16284748780-19d75b9d1-01a1-f424-e053-dadaa90a57ceAM-10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0349-1AM-1029.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0349AM-10 (NERIUM OLEANDER LEAF, TRIBASIC CALCIUM PHOSPHATE, AND CARBO ANIMALIS) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_d9cee2a4-1990-4aba-83b0-c1f28e488bd2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0349-15826403490129.57 mL in 1 BOTTLE, GLASS (58264-0349-1) 29.57 ml1990-01-010000-00-00NoNoCurrent