D-27

Product NDC
58264-0027
Requested package NDC
58264-0027-1
11-digit product format
582640027
Labeler code
58264
Product ID
58264-0027_2b9eb825-2e80-846c-e063-6394a90a0a7b
Type
HUMAN OTC DRUG
Nonproprietary name
BERBERIS VULGARIS ROOT BARK, NITRIC ACID, CALCIUM FLUORIDE, LYCOPODIUM CLAVATUM SPORE, RUBIA TINCTORUM ROOT, and SMILAX ORNATA ROOT
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
BERBERIS VULGARIS ROOT BARK; NITRIC ACID; CALCIUM FLUORIDE; LYCOPODIUM CLAVATUM SPORE; RUBIA TINCTORUM ROOT; SMILAX ORNATA ROOT
Active strength
3; 6; 12; 5; 2; 3 [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 · 6 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…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
D-27
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
NITRIC ACID6 [hp_X]/mL
CALCIUM FLUORIDE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE5 [hp_X]/mL
RUBIA TINCTORUM ROOT2 [hp_X]/mL
SMILAX ORNATA ROOT3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1TH8Q20J0UInternal UNII lookup
411VRN1TV4Internal UNII lookup
O3B55K4YKIInternal UNII lookup
C88X29Y479Internal UNII lookup
0SVP95L23GInternal UNII lookup
2H1576D5WGInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
85b13ca5-a35f-4118-93ce-985d4ea9258cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0027-12022-06-02C16284748780-19d75b9d0-50ce-f424-e053-dadaa90a57ceD-27
58264-0027-12020-01-31C16284748780-19d75b9d0-50ce-f424-e053-dadaa90a57ceD-27

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0027-1D-2729.57 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0027D-27 (BERBERIS VULGARIS ROOT BARK, NITRIC ACID, CALCIUM FLUORIDE, LYCOPODIUM CLAVATUM SPORE, RUBIA TINCTORUM ROOT, AND SMILAX ORNATA ROOT) SOLUTION/ DROPS [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_85b13ca5-a35f-4118-93ce-985d4ea9258c.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-27BERBERIS VULGARIS ROOT BARK, NITRIC ACID, CALCIUM FLUORIDE, LYCOPODIUM CLAVATUM SPORE, RUBIA TINCTORUM ROOT, AND SMILAX ORNATA ROOTDNA Labs, Inc.85b13ca5-a35f-4118-93ce-985d4ea9258c2025-01-13WarningsExact identifier
ndc (package): 58264-0027-1
ndc (product): 58264-0027
ndc11 (package): 58264002701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0027-15826400270129.57 mL in 1 BOTTLE, GLASS (58264-0027-1) 29.57 ml1990-01-010000-00-00NoNoCurrent