N-2

Product NDC
58264-0200
Requested package NDC
58264-0200-1
11-digit product format
582640200
Labeler code
58264
Product ID
58264-0200_2b53985a-2333-fd8d-e063-6294a90a8bbc
Type
HUMAN OTC DRUG
Nonproprietary name
SELENICEREUS GRANDIFLORUS WHOLE, CRATAEGUS LAEVIGATA WHOLE, DIBASIC POTASSIUM PHOSPHATE, Arnica montana, VALERIANA OFFICINALIS WHOLE, Spigelia anthelmia, and BEEF HEART
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
SELENICEREUS GRANDIFLORUS WHOLE; CRATAEGUS LAEVIGATA WHOLE; DIBASIC POTASSIUM PHOSPHATE; ARNICA MONTANA; VALERIANA OFFICINALIS WHOLE; SPIGELIA ANTHELMIA; BEEF HEART
Active strength
3; 3; 6; 6; 4; 8; 200 [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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
N-2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENICEREUS GRANDIFLORUS WHOLE3 [hp_X]/mL
CRATAEGUS LAEVIGATA WHOLE3 [hp_X]/mL
DIBASIC POTASSIUM PHOSPHATE6 [hp_X]/mL
ARNICA MONTANA6 [hp_X]/mL
VALERIANA OFFICINALIS WHOLE4 [hp_X]/mL
SPIGELIA ANTHELMIA8 [hp_X]/mL
BEEF HEART200 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X8H7HS7MRMInternal UNII lookup
EFX9G567MJInternal UNII lookup
CI71S98N1ZInternal UNII lookup
O80TY208ZWInternal UNII lookup
FP6O7F1X9RInternal UNII lookup
WYT05213GEInternal UNII lookup
P47W069U38Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
29e3bc19-e3b6-4337-b8df-13b8b8b8da9fAvailable on FDA.report

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
58264-0200-12022-06-06C16284748780-19d75b9d0-3d8a-f424-e053-dadaa90a57ceN-2
58264-0200-12020-01-31C16284748780-19d75b9d0-3d8a-f424-e053-dadaa90a57ceN-2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0200-1N-229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0200N-2 (SELENICEREUS GRANDIFLORUS WHOLE, CRATAEGUS LAEVIGATA WHOLE, DIBASIC POTASSIUM PHOSPHATE, ARNICA MONTANA, VALERIANA OFFICINALIS WHOLE, SPIGELIA ANTHELMIA, AND BEEF HEART) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_29e3bc19-e3b6-4337-b8df-13b8b8b8da9f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
N-2SELENICEREUS GRANDIFLORUS WHOLE, CRATAEGUS LAEVIGATA WHOLE, DIBASIC POTASSIUM PHOSPHATE, ARNICA MONTANA, VALERIANA OFFICINALIS WHOLE, SPIGELIA ANTHELMIA, AND BEEF HEARTDNA Labs, Inc.29e3bc19-e3b6-4337-b8df-13b8b8b8da9f2025-01-09WarningsExact identifier
ndc (package): 58264-0200-1
ndc (product): 58264-0200
ndc11 (package): 58264020001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0200-15826402000129.57 mL in 1 BOTTLE, GLASS (58264-0200-1) 29.57 ml1990-01-010000-00-00NoNoCurrent