FDA.reportPublic FDA data

AM-13

Product NDC
58264-0352
11-digit product format
582640352
Labeler code
58264
Product ID
58264-0352_2b530d94-bb57-3c78-e063-6294a90a8ec5
Type
HUMAN OTC DRUG
Nonproprietary name
CARBON DISULFIDE, SILVER NITRATE, CORALLIUM RUBRUM WHOLE, CUPRIC ARSENITE, ASIAN GINSENG, Hypericum perforatum, LATHYRUS SATIVUS WHOLE, PICRIC ACID, SELENIUM, DATURA STRAMONIUM WHOLE, and ZINC
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ASIAN GINSENG; CARBON DISULFIDE; CORALLIUM RUBRUM WHOLE; CUPRIC ARSENITE; DATURA STRAMONIUM WHOLE; HYPERICUM PERFORATUM; LATHYRUS SATIVUS WHOLE; PICRIC ACID; SELENIUM; SILVER NITRATE; ZINC
Active strength
3; 30; 30; 8; 30; 6; 30; 12; 30; 6; 30 [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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AM-13
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASIAN GINSENG3 [hp_X]/mL
CARBON DISULFIDE30 [hp_X]/mL
CORALLIUM RUBRUM WHOLE30 [hp_X]/mL
CUPRIC ARSENITE8 [hp_X]/mL
DATURA STRAMONIUM WHOLE30 [hp_X]/mL
HYPERICUM PERFORATUM6 [hp_X]/mL
LATHYRUS SATIVUS WHOLE30 [hp_X]/mL
PICRIC ACID12 [hp_X]/mL
SELENIUM30 [hp_X]/mL
SILVER NITRATE6 [hp_X]/mL
ZINC30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCUQ3A77YXI, S54S8B99E8, 22Z32PWR7R, SK8L60BCSQ, FI8B4CLS9I, XK4IUX8MNB, MX7553JF12, A49OS0F91S, H6241UJ22B, 95IT3W8JZE, J41CSQ7QDS

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
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0352-12022-06-02C16284748780-19d75b9d0-ee42-f424-e053-dadaa90a57ceAM-13
58264-0352-12020-01-31C16284748780-19d75b9d0-ee42-f424-e053-dadaa90a57ceAM-13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0352-1AM-1329.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0352AM-13 (CARBON DISULFIDE, SILVER NITRATE, CORALLIUM RUBRUM WHOLE, CUPRIC ARSENITE, ASIAN GINSENG, HYPERICUM PERFORATUM, LATHYRUS SATIVUS WHOLE, PICRIC ACID, SELENIUM, DATURA STRAMONIUM WHOLE, AND ZINC) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_735d1d54-dd9d-4867-bfdf-3003d7403953.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0352-15826403520129.57 mL in 1 BOTTLE, GLASS (58264-0352-1) 29.57 ml1990-01-010000-00-00NoNoCurrent