N-4

Product NDC
58264-0202
11-digit product format
582640202
Labeler code
58264
Product ID
58264-0202_2b538be3-baa7-3c2b-e063-6294a90a1489
Type
HUMAN OTC DRUG
Nonproprietary name
Chelidonium majus, Bryonia alba root, STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM WHOLE, MAMMAL LIVER, SODIUM SULFATE, and MILK THISTLE
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM WHOLE; MAMMAL LIVER; MILK THISTLE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED
Active strength
4; 4; 4; 200; 4; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58264-0202-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0202-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0202-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0202-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0202-19bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
N-4
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHELIDONIUM MAJUS4 [hp_X]/mL
BRYONIA ALBA ROOT4 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED4 [hp_X]/mL
LYCOPODIUM CLAVATUM WHOLE200 [hp_X]/mL
MAMMAL LIVER4 [hp_X]/mL
SODIUM SULFATE4 [hp_X]/mL
MILK THISTLE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7E889U5RNNInternal UNII lookup
T7J046YI2BInternal UNII lookup
269XH13919Internal UNII lookup
005ICF6L27Internal UNII lookup
0YPR65R21JInternal UNII lookup
U946SH95EEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e3f6d49-f11d-439b-b94a-211e4b084b5eAvailable on FDA.report

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
58264-0202-12022-06-06C16284748780-19d75b9d0-ee12-f424-e053-dadaa90a57ceN-4
58264-0202-12020-01-31C16284748780-19d75b9d0-ee12-f424-e053-dadaa90a57ceN-4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0202-1N-429.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0202N-4 (CHELIDONIUM MAJUS, BRYONIA ALBA ROOT, STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM WHOLE, MAMMAL LIVER, SODIUM SULFATE, AND MILK THISTLE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_4e3f6d49-f11d-439b-b94a-211e4b084b5e.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-4CHELIDONIUM MAJUS, BRYONIA ALBA ROOT, STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM WHOLE, MAMMAL LIVER, SODIUM SULFATE, AND MILK THISTLEDNA Labs, Inc.4e3f6d49-f11d-439b-b94a-211e4b084b5e2025-01-09WarningsExact identifier
ndc (product): 58264-0202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0202-15826402020129.57 mL in 1 BOTTLE, GLASS (58264-0202-1) 29.57 ml1990-01-010000-00-00NoNoCurrent