D-13

Product NDC
58264-0013
11-digit product format
582640013
Labeler code
58264
Product ID
58264-0013_2b9ea4e9-9a52-adab-e063-6394a90a8323
Type
HUMAN OTC DRUG
Nonproprietary name
HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, STRYCHNOS NUX-VOMICA SEED, GRAPHITE, SULFUR, COLLINSONIA CANADENSIS ROOT, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, and NITRIC ACID
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
COLLINSONIA CANADENSIS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS ROOT; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR
Active strength
4; 8; 3; 2; 5; 6; 3; 6; 4; 5 [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
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58264-0013-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58264-0013-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0013-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0013-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0013-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0013-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HORSE CHESTNUT2 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]/mL
PAEONIA OFFICINALIS ROOT3 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED4 [hp_X]/mL
GRAPHITE8 [hp_X]/mL
SULFUR5 [hp_X]/mL
COLLINSONIA CANADENSIS ROOT4 [hp_X]/mL
POTASSIUM CARBONATE6 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE5 [hp_X]/mL
NITRIC ACID6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3C18L6RJAZInternal UNII lookup
T7S323PKJSInternal UNII lookup
8R564U2E1PInternal UNII lookup
269XH13919Internal UNII lookup
4QQN74LH4OInternal UNII lookup
70FD1KFU70Internal UNII lookup
O2630F3XDRInternal UNII lookup
BQN1B9B9HAInternal UNII lookup
C88X29Y479Internal UNII lookup
411VRN1TV4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
047a2c0e-9b59-45c3-85df-0a26cdc39719Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0013-12022-06-02C16284748780-19d75b9d0-248b-f424-e053-dadaa90a57ceD-13
58264-0013-12020-01-31C16284748780-19d75b9d0-248b-f424-e053-dadaa90a57ceD-13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0013-1D-1329.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0013D-13 (HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, STRYCHNOS NUX-VOMICA SEED, GRAPHITE, SULFUR, COLLINSONIA CANADENSIS ROOT, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, AND NITRIC ACID) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_047a2c0e-9b59-45c3-85df-0a26cdc39719.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
D-13HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, STRYCHNOS NUX-VOMICA SEED, GRAPHITE, SULFUR, COLLINSONIA CANADENSIS ROOT, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, AND NITRIC ACIDDNA Labs, Inc.047a2c0e-9b59-45c3-85df-0a26cdc397192025-01-13WarningsExact identifier
ndc (product): 58264-0013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0013-15826400130129.57 mL in 1 BOTTLE, GLASS (58264-0013-1) 29.57 ml1990-01-010000-00-00NoNoCurrent