Home NDC 58264-0016-1 D-16
Product NDC 58264-0016
Requested package NDC 58264-0016-1
11-digit product format 582640016
Labeler code 58264
Product ID 58264-0016_2b9ea65c-9dfc-ad89-e063-6394a90ab44c
Type HUMAN OTC DRUG
Nonproprietary name black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia
Dosage form SOLUTION/ DROPS
Route SUBLINGUAL
Labeler DNA Labs, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1990-01-01
Substance BLACK COHOSH; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; GELSEMIUM SEMPERVIRENS ROOT; SPIGELIA ANTHELMIA
Active strength 4; 2; 2; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base D-16
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BLACK COHOSH 4 [hp_X]/mL IRIS VERSICOLOR ROOT 2 [hp_X]/mL SANGUINARIA CANADENSIS ROOT 2 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]/mL SPIGELIA ANTHELMIA 4 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58264-0016-1 D-16 29.57 mL in 1 BOTTLE, GLASS SOLUTION/ DROPS 29.57 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58264-0016 D-16 (BLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, AND SPIGELIA ANTHELMIA) SOLUTION/ DROPS [DNA LABS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250115_4784ddc2-c308-4092-a01f-ea2b2954a888.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join D-16 BLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, AND SPIGELIA ANTHELMIA DNA Labs, Inc. 4784ddc2-c308-4092-a01f-ea2b2954a888 2025-01-13 Warnings Exact identifier ndc (package): 58264-0016-1 ndc (product): 58264-0016 ndc11 (package): 58264001601
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0016-1 58264001601 29.57 mL in 1 BOTTLE, GLASS (58264-0016-1) 29.57 ml 1990-01-01 0000-00-00 No No Current