FDA.reportPublic FDA data

N-23

Product NDC
58264-0221
11-digit product format
582640221
Labeler code
58264
Product ID
58264-0221_2b539b74-75a5-e36c-e063-6294a90ae2dd
Type
HUMAN OTC DRUG
Nonproprietary name
Anemone pulsatilla, Phosphorus, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, and BOS TAURUS HYPOTHALAMUS
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ANEMONE PULSATILLA; ARSENIC TRIOXIDE; BOS TAURUS HYPOTHALAMUS; NITRIC ACID; PHOSPHORUS; SILICON DIOXIDE; TOXICODENDRON PUBESCENS WHOLE
Active strength
6; 12; 200; 6; 6; 10; 6 [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
N-23
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANEMONE PULSATILLA6 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
BOS TAURUS HYPOTHALAMUS200 [hp_X]/mL
NITRIC ACID6 [hp_X]/mL
PHOSPHORUS6 [hp_X]/mL
SILICON DIOXIDE10 [hp_X]/mL
TOXICODENDRON PUBESCENS WHOLE6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI76KB35JEV, S7V92P67HO, S6G2NLH4Y7, 411VRN1TV4, 27YLU75U4W, ETJ7Z6XBU4, C1S185Y74S

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0221-12022-06-06C16284748780-19d75b9d0-698e-f424-e053-dadaa90a57ceN-23
58264-0221-12020-01-31C16284748780-19d75b9d0-698e-f424-e053-dadaa90a57ceN-23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0221-1N-2329.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0221N-23 (ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUS) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_b6365b49-06fb-4692-96f7-a5097b70bc91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0221-15826402210129.57 mL in 1 BOTTLE, GLASS (58264-0221-1) 29.57 ml1990-01-010000-00-00NoNoCurrent