D-107

Product NDC
58264-0113
11-digit product format
582640113
Labeler code
58264
Product ID
58264-0113_2b9ed994-a888-0e65-e063-6394a90aca84
Type
HUMAN OTC DRUG
Nonproprietary name
Actaea Spicata Root, Arnica montana, Caulophyllum thalictroides Root, Magnesium phosphate, dibasic trihydrate, Oxalic acid, Sepia officinalis juice, Cola acuminata seed, Stellaria media, and Toxicodendron pubescens leaf
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ACTAEA SPICATA ROOT; ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; COLA ACUMINATA SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID; SEPIA OFFICINALIS JUICE; STELLARIA MEDIA; TOXICODENDRON PUBESCENS LEAF
Active strength
30; 6; 30; 6; 6; 8; 12; 6; 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], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], 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
D-107
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTAEA SPICATA ROOT30 [hp_X]/mL
ARNICA MONTANA6 [hp_X]/mL
CAULOPHYLLUM THALICTROIDES ROOT30 [hp_X]/mL
COLA ACUMINATA SEED6 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]/mL
OXALIC ACID8 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
STELLARIA MEDIA6 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FU86L9OS0, O80TY208ZW, JTJ6HH6YEH, 1F8VIW1479, HF539G9L3Q, 9E7R5L6H31, QDL83WN8C2, 2H03479QVR, 6IO182RP7A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0113-12022-06-06C16284748780-19d75b9d0-8f17-f424-e053-dadaa90a57ceD-107
58264-0113-12020-01-31C16284748780-19d75b9d0-8f17-f424-e053-dadaa90a57ceD-107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0113-1D-10729.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0113D-107 (ACTAEA SPICATA ROOT, ARNICA MONTANA, CAULOPHYLLUM THALICTROIDES ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, OXALIC ACID, SEPIA OFFICINALIS JUICE, COLA ACUMINATA SEED, STELLARIA MEDIA, AND TOXICODENDRON PUBESCENS LEAF) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_e12a693d-cf0b-48d6-9317-a54d146005e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0113-15826401130129.57 mL in 1 BOTTLE, GLASS (58264-0113-1) 29.57 ml1990-01-010000-00-00NoNoCurrent