Home NDC 58264-0230 N-22
Product NDC 58264-0230
11-digit product format 582640230
Labeler code 58264
Product ID 58264-0230_f0ffc043-bfe4-5986-e053-2995a90a7ec1
Type HUMAN OTC DRUG
Nonproprietary name APIS MELLIFERA, PILOCARPUS MICROPHYLLUS LEAF, TRIFOLIUM REPENS WHOLE, ATROPA BELLADONNA, BARIUM CARBONATE, FERROSOFERRIC PHOSPHATE, POTASSIUM DICHROMATE, PHYTOLACCA AMERICANA WHOLE, ANEMONE PULSATILLA, MERCURIUS SOLUBILIS and BOS TAURUS PAROTID GLAND
Dosage form SOLUTION
Route SUBLINGUAL
Labeler DNA Labs, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1990-01-01
Marketing end 0000-00-00
Substance ANEMONE PULSATILLA; APIS MELLIFERA; ATROPA BELLADONNA; BARIUM CARBONATE; BOS TAURUS PAROTID GLAND; FERROSOFERRIC PHOSPHATE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA WHOLE; PILOCARPUS MICROPHYLLUS LEAF; POTASSIUM DICHROMATE; TRIFOLIUM REPENS WHOLE
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; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58264-0230-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58264-0230-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58264-0230-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58264-0230-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58264-0230-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58264-0230-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58264-0230-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58264-0230-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58264-0230-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58264-0230-1 N-22 29.57 mL in 1 BOTTLE, GLASS SOLUTION 29.57 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58264-0230 N-22 (APIS MELLIFERA, PILOCARPUS MICROPHYLLUS LEAF, TRIFOLIUM REPENS WHOLE, ATROPA BELLADONNA, BARIUM CARBONATE, FERROSOFERRIC PHOSPHATE, POTASSIUM DICHROMATE, PHYTOLACCA AMERICANA WHOLE, ANEMONE PULSATILLA, MERCURIUS SOLUBILIS AND BOS TAURUS PAROTID GLAND) SOLUTION [DNA LABS, INC.] 1 Legacy NDC, 1 package rows 20230101_f0ffc043-bfe3-5986-e053-2995a90a7ec1.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0230-1 58264023001 29.57 mL in 1 BOTTLE, GLASS (58264-0230-1) 29.57 ml 1990-01-01 0000-00-00 No No Current