D14

Product NDC
58264-0014
11-digit product format
582640014
Labeler code
58264
Product ID
58264-0014_e082b62a-5b77-c759-e053-2995a90a9c16
Type
HUMAN OTC DRUG
Nonproprietary name
Avena sativa whole, Valeriana officinalis whole, Humulus lupulus whole, Arabica coffee bean, Strychnos ignatii whole, zinc valerate dihydrate, Ammonium bromide, Chamomile, Eschscholzia Californica, and Passiflora incarnata whole
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Marketing end
0000-00-00
Substance
AMMONIUM BROMIDE; ARABICA COFFEE BEAN; AVENA SATIVA WHOLE; CHAMOMILE; ESCHSCHOLZIA CALIFORNICA; HUMULUS LUPULUS WHOLE; PASSIFLORA INCARNATA WHOLE; STRYCHNOS IGNATII WHOLE; VALERIANA OFFICINALIS WHOLE; ZINC VALERATE DIHYDRATE
Active strength
3 [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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58264-0014DDiscontinued by firm2026-08-17
excluded packagepackage58264-001458264-0014-1DDiscontinued by firm2026-08-17

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58264-0014-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58264-0014-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0014-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0014-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0014-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0014-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0014-12022-06-02C16284748780-19d75b9d0-ed1f-f424-e053-dadaa90a57ceD-14
58264-0014-12020-01-31C16284748780-19d75b9d0-ed1f-f424-e053-dadaa90a57ceD-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0014D14 (AVENA SATIVA WHOLE, VALERIANA OFFICINALIS WHOLE, HUMULUS LUPULUS WHOLE, ARABICA COFFEE BEAN, STRYCHNOS IGNATII WHOLE, ZINC VALERATE DIHYDRATE, AMMONIUM BROMIDE, CHAMOMILE, ESCHSCHOLZIA CALIFORNICA, AND PASSIFLORA INCARNATA WHOLE) SOLUTION [DNA LABS, INC.]3Legacy NDC20250115_4096bbed-b752-4082-a07c-79fc497fb8cc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0014-15826400140129.57 mL in 1 BOTTLE, GLASS (58264-0014-1) 29.57 ml1990-01-010000-00-00NoNoCurrent