D134

Product NDC
58264-0140
11-digit product format
582640140
Labeler code
58264
Product ID
58264-0140_2b9edb0e-499f-f422-e063-6294a90ae8fa
Type
HUMAN OTC DRUG
Nonproprietary name
BLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, Causticum, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, and TRIBASIC CALCIUM PHOSPHATE
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ARNICA MONTANA; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA WHOLE; CAUSTICUM; CITRULLUS COLOCYNTHIS WHOLE; FERROSOFERRIC PHOSPHATE; KALMIA LATIFOLIA WHOLE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RHODODENDRON AUREUM WHOLE; SODIUM SULFATE ANHYDROUS; SOLANUM DULCAMARA WHOLE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS WHOLE; TRIBASIC CALCIUM PHOSPHATE
Active strength
5; 8; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 4; 8 [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D134
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLACK COHOSH5 [hp_X]/mL
BRYONIA ALBA WHOLE8 [hp_X]/mL
TOXICODENDRON PUBESCENS WHOLE3 [hp_X]/mL
ARNICA MONTANA4 [hp_X]/mL
CAUSTICUM6 [hp_X]/mL
FERROSOFERRIC PHOSPHATE6 [hp_X]/mL
SODIUM SULFATE ANHYDROUS6 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED6 [hp_X]/mL
RHODODENDRON AUREUM WHOLE6 [hp_X]/mL
CITRULLUS COLOCYNTHIS WHOLE6 [hp_X]/mL
SOLANUM DULCAMARA WHOLE6 [hp_X]/mL
KALMIA LATIFOLIA WHOLE6 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]/mL
ARSENIC TRIOXIDE4 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK73E24S6X9, 56K0VVT47P, C1S185Y74S, O80TY208ZW, DD5FO1WKFU, 91GQH8I5F7, 36KCS0R750, 269XH13919, MM2Y21LFIT, Z70W98921V, G72JA9DHK5, P1SWF7DK1Y, HF539G9L3Q, S7V92P67HO, 91D9GV0Z28

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0140-12022-06-06C16284748780-19d75b9d1-1980-f424-e053-dadaa90a57ceD134
58264-0140-12020-01-31C16284748780-19d75b9d1-1980-f424-e053-dadaa90a57ceD134

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0140-1D13429.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0140D134 (BLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, CAUSTICUM, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, AND TRIBASIC CALCIUM PHOSPHATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_a1d4d74a-75ca-45f8-8787-7ac6aa726932.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0140-15826401400129.57 mL in 1 BOTTLE, GLASS (58264-0140-1) 29.57 ml1990-01-010000-00-00NoNoCurrent