D81

Product NDC
58264-0082
11-digit product format
582640082
Labeler code
58264
Product ID
58264-0082_2b9ed194-def4-363e-e063-6294a90a8cdc
Type
HUMAN OTC DRUG
Nonproprietary name
PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, and LARREA DIVARICATA WHOLE
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ARCTIUM LAPPA WHOLE; BERBERIS VULGARIS WHOLE; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA WHOLE; LARREA DIVARICATA WHOLE; PASSIFLORA INCARNATA WHOLE; PHYTOLACCA AMERICANA ROOT; PRUNUS DULCIS WHOLE; SMILAX ORNATA WHOLE; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE WHOLE
Active strength
1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1 [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; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D81
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTIUM LAPPA WHOLE1 [hp_X]/mL
BERBERIS VULGARIS WHOLE1 [hp_X]/mL
FRANGULA PURSHIANA BARK1 [hp_X]/mL
GLYCYRRHIZA GLABRA WHOLE1 [hp_X]/mL
LARREA DIVARICATA WHOLE1 [hp_X]/mL
PASSIFLORA INCARNATA WHOLE1 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT1 [hp_X]/mL
PRUNUS DULCIS WHOLE1 [hp_X]/mL
SMILAX ORNATA WHOLE1 [hp_X]/mL
STILLINGIA SYLVATICA ROOT1 [hp_X]/mL
TRIFOLIUM PRATENSE WHOLE1 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73070DU1LA, 492B79913J, 4VBP01X99F, M1F96IE0ZC, 89VP85U2R1, R48E2W2LMO, 11E6VI8VEG, X3EC86GF0Z, SJO6NF5H81, QBR70R4FBK, FG30UR681Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0082-12022-06-06C16284748780-19d75b9d0-3ca0-f424-e053-dadaa90a57ceD-81
58264-0082-12020-01-31C16284748780-19d75b9d0-3ca0-f424-e053-dadaa90a57ceD-81

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0082-1D8129.57 mL in 1 BOTTLE, GLASSSOLUTION29.574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0082D81 (PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, AND LARREA DIVARICATA WHOLE) SOLUTION [DNA LABS, INC.]4Current NDC, Legacy NDC, 1 package rows20250115_42bffb7a-ca76-4cbb-b5c9-b677e93b6d31.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0082-15826400820129.57 mL in 1 BOTTLE, GLASS (58264-0082-1) 29.57 ml1990-01-010000-00-00NoNoCurrent