FDA.reportPublic FDA data

AM-2

Product NDC
58264-0341
11-digit product format
582640341
Labeler code
58264
Product ID
58264-0341_2b52d8d8-5796-e0ae-e063-6394a90af1e6
Type
HUMAN OTC DRUG
Nonproprietary name
COLCHICUM AUTUMNALE WHOLE, SODIUM SULFATE ANHYDROUS, and NAJA NAJA WHOLE
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
COLCHICUM AUTUMNALE WHOLE; NAJA NAJA WHOLE; SODIUM SULFATE ANHYDROUS
Active strength
12; 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-2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICUM AUTUMNALE WHOLE12 [hp_X]/mL
SODIUM SULFATE ANHYDROUS12 [hp_X]/mL
NAJA NAJA WHOLE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW79255C628, 36KCS0R750, D279BDR31E

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0341-12022-06-02C16284748780-19d75b9cf-ce7e-f424-e053-dadaa90a57ceAM-2
58264-0341-12020-01-31C16284748780-19d75b9cf-ce7e-f424-e053-dadaa90a57ceAM-2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0341-1AM-229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0341AM-2 (COLCHICUM AUTUMNALE WHOLE, SODIUM SULFATE ANHYDROUS, AND NAJA NAJA WHOLE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_2839f10b-897b-41cb-b0ca-c2e051765d5c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0341-15826403410129.57 mL in 1 BOTTLE, GLASS (58264-0341-1) 29.57 ml1990-01-010000-00-00NoNoCurrent