D-11

Product NDC
58264-0011
11-digit product format
582640011
Labeler code
58264
Product ID
58264-0011_2b9ea4e9-9a51-adab-e063-6394a90a8323
Type
HUMAN OTC DRUG
Nonproprietary name
BERBERIS VULGARIS ROOT BARK, SOLANUM DULCAMARA WHOLE, TOXICODENDRON PUBESCENS LEAF, STRYCHNOS NUX-VOMICA SEED, Causticum, TRIBASIC CALCIUM PHOSPHATE, and RHODODENDRON AUREUM LEAF
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
BERBERIS VULGARIS ROOT BARK; CAUSTICUM; RHODODENDRON AUREUM LEAF; SOLANUM DULCAMARA WHOLE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE
Active strength
4; 6; 4; 4; 4; 4; 12 [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

Additional Listing Data#

Finished product
Yes
Brand name base
D-11
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK4 [hp_X]/mL
CAUSTICUM6 [hp_X]/mL
RHODODENDRON AUREUM LEAF4 [hp_X]/mL
SOLANUM DULCAMARA WHOLE4 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED4 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF4 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1TH8Q20J0U, DD5FO1WKFU, IV92NQJ73U, G72JA9DHK5, 269XH13919, 6IO182RP7A, 91D9GV0Z28

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0011-12022-06-02C16284748780-19d75b9d1-0159-f424-e053-dadaa90a57ceD-11
58264-0011-12020-01-31C16284748780-19d75b9d1-0159-f424-e053-dadaa90a57ceD-11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0011-1D-1129.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0011D-11 (BERBERIS VULGARIS ROOT BARK, SOLANUM DULCAMARA WHOLE, TOXICODENDRON PUBESCENS LEAF, STRYCHNOS NUX-VOMICA SEED, CAUSTICUM, TRIBASIC CALCIUM PHOSPHATE, AND RHODODENDRON AUREUM LEAF) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_6620ef7e-3b89-49cc-bae6-13bad0000ada.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0011-15826400110129.57 mL in 1 BOTTLE, GLASS (58264-0011-1) 29.57 ml1990-01-010000-00-00NoNoCurrent