Home NDC 58264-0346-1 AM-7
Product NDC 58264-0346
Requested package NDC 58264-0346-1
11-digit product format 582640346
Labeler code 58264
Product ID 58264-0346_2b530979-bfa8-24b5-e063-6394a90a76eb
Type HUMAN OTC DRUG
Nonproprietary name Strychnos nux-vomica seed, Sodium Phosphate, Dibasic, Heptahydrate, and BUFO BUFO WHOLE
Dosage form SOLUTION
Route SUBLINGUAL
Labeler DNA Labs, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1990-01-01
Substance STRYCHNOS NUX-VOMICA SEED; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; BUFO BUFO WHOLE
Active strength 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base AM-7
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STRYCHNOS NUX-VOMICA SEED 8 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 8 [hp_X]/mL BUFO BUFO WHOLE 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 269XH13919 Internal UNII lookup 70WT22SF4B Internal UNII lookup DP1U601YQS Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58264-0346-1 AM-7 29.57 mL in 1 BOTTLE, GLASS SOLUTION 29.57 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58264-0346 AM-7 (STRYCHNOS NUX-VOMICA SEED, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND BUFO BUFO WHOLE) SOLUTION [DNA LABS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250112_c913d2ca-dd24-4139-b61b-2c1d267cc4e8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0346-1 58264034601 29.57 mL in 1 BOTTLE, GLASS (58264-0346-1) 29.57 ml 1990-01-01 0000-00-00 No No Current