D-61

Product NDC
58264-0061
11-digit product format
582640061
Labeler code
58264
Product ID
58264-0061_2b9eda10-4e91-e31e-e063-6394a90a53c6
Type
HUMAN OTC DRUG
Nonproprietary name
tobacco leaf, salix nigra bark, camphor (natural), turpentine oil, berberis vulgaris root bark, solanum dulcamara whole, strychnos nux-vomica seed, rhododendron aureum leaf, and toxicodendron pubescens leaf
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
BERBERIS VULGARIS ROOT BARK; CAMPHOR (NATURAL); RHODODENDRON AUREUM LEAF; SALIX NIGRA BARK; SOLANUM DULCAMARA WHOLE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; TURPENTINE OIL
Active strength
2; 6; 3; 3; 2; 2; 12; 3; 6 [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], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-61
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK2 [hp_X]/mL
CAMPHOR (NATURAL)6 [hp_X]/mL
RHODODENDRON AUREUM LEAF3 [hp_X]/mL
SALIX NIGRA BARK3 [hp_X]/mL
SOLANUM DULCAMARA WHOLE2 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED2 [hp_X]/mL
TOBACCO LEAF12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF3 [hp_X]/mL
TURPENTINE OIL6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1TH8Q20J0U, N20HL7Q941, IV92NQJ73U, QU52J3A5B3, G72JA9DHK5, 269XH13919, 6YR2608RSU, 6IO182RP7A, C5H0QJ6V7F

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0061-12022-06-03C16284748780-19d75b9d0-5221-f424-e053-dadaa90a57ceD-61
58264-0061-12020-01-31C16284748780-19d75b9d0-5221-f424-e053-dadaa90a57ceD-61

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0061-1D-6129.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0061D-61 (TOBACCO LEAF, SALIX NIGRA BARK, CAMPHOR (NATURAL), TURPENTINE OIL, BERBERIS VULGARIS ROOT BARK, SOLANUM DULCAMARA WHOLE, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM LEAF, AND TOXICODENDRON PUBESCENS LEAF) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_5582d3d0-cf33-45d8-b3fb-5bf85e15bdfa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0061-15826400610129.57 mL in 1 BOTTLE, GLASS (58264-0061-1) 29.57 ml1990-01-010000-00-00NoNoCurrent