D-111

Product NDC
58264-0117
11-digit product format
582640117
Labeler code
58264
Product ID
58264-0117_e0bb5f74-da51-7a81-e053-2995a90a4f27
Type
HUMAN OTC DRUG
Nonproprietary name
matricaria chamomilla, rheum officinale root, atropa belladonna, arabica coffee bean, tribasic calcium phosphate, calcium fluoride, magnesium phosphate, dibasic trihydrate, oyster shell calcium carbonate, crude, and wood creosote
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Marketing end
0000-00-00
Substance
ARABICA COFFEE BEAN; ATROPA BELLADONNA; CALCIUM FLUORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RHEUM OFFICINALE ROOT; TRIBASIC CALCIUM PHOSPHATE; WOOD CREOSOTE
Active strength
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0117-12022-06-06C16284748780-19d75b9d0-3649-f424-e053-dadaa90a57ce5183ad26-c8cf-4c78-9d95-82ea4d696215
58264-0117-12020-01-31C16284748780-19d75b9d0-3649-f424-e053-dadaa90a57ce5183ad26-c8cf-4c78-9d95-82ea4d696215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0117D-111 (MATRICARIA CHAMOMILLA, RHEUM OFFICINALE ROOT, ATROPA BELLADONNA, ARABICA COFFEE BEAN, TRIBASIC CALCIUM PHOSPHATE, CALCIUM FLUORIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND WOOD CREOSOTE) SOLUTION [DNA LABS, INC.]3Legacy NDC20250115_5183ad26-c8cf-4c78-9d95-82ea4d696215.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0117-15826401170129.57 mL in 1 BOTTLE, GLASS (58264-0117-1) 29.57 ml1990-01-010000-00-00NoNoCurrent