G-15

Product NDC
58264-0378
Requested package NDC
58264-0378-2
11-digit product format
582640378
Labeler code
58264
Product ID
58264-0378_2b53436d-6db5-6987-e063-6294a90ad24f
Type
HUMAN OTC DRUG
Nonproprietary name
Hawthorn leaf with flower
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
HAWTHORN LEAF WITH FLOWER
Active strength
1 [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…

Additional Listing Data#

Finished product
Yes
Brand name base
G-15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HAWTHORN LEAF WITH FLOWER1 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6OM09RPY36Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
677f907b-a315-48b7-8b01-b5fa866bef3fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0378-22022-06-08C16284748780-19d75b9d1-1212-f424-e053-dadaa90a57ceG-15
58264-0378-22020-01-31C16284748780-19d75b9d1-1212-f424-e053-dadaa90a57ceG-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0378-2G-1559.14 mL in 1 BOTTLE, GLASSSOLUTION59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0378G-15 (HAWTHORN LEAF WITH FLOWER) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_677f907b-a315-48b7-8b01-b5fa866bef3f.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
G-15HAWTHORN LEAF WITH FLOWERDNA Labs, Inc.677f907b-a315-48b7-8b01-b5fa866bef3f2025-01-09WarningsExact identifier
ndc (package): 58264-0378-2
ndc (product): 58264-0378
ndc11 (package): 58264037802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0378-25826403780259.14 mL in 1 BOTTLE, GLASS (58264-0378-2) 59.14 ml1990-01-010000-00-00NoNoCurrent