Home NDC 58264-0117-1 D-111
Product NDC 58264-0117
Requested package NDC 58264-0117-1
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58264-0117 D-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.] 3 Legacy NDC 20250115_5183ad26-c8cf-4c78-9d95-82ea4d696215.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0117-1 58264011701 29.57 mL in 1 BOTTLE, GLASS (58264-0117-1) 29.57 ml 1990-01-01 0000-00-00 No No Current