FDA.reportPublic FDA data

N-17

Product NDC
58264-0215
11-digit product format
582640215
Labeler code
58264
Product ID
58264-0215_2b538be3-baaa-3c2b-e063-6294a90a1489
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc, Selenium, Bos taurus thymus, Sus Scrofa Spleen, Bos taurus lymph, Bos taurus adrenal gland, Arginine, Cystine, Echinacea angustifolia, Thiamine, Pyridoxine hydrochloride, and Ascorbic acid
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ARGININE; ASCORBIC ACID; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH; BOS TAURUS THYMUS; CYSTINE; ECHINACEA ANGUSTIFOLIA; PYRIDOXINE HYDROCHLORIDE; SELENIUM; SUS SCROFA SPLEEN; THIAMINE; ZINC
Active strength
4; 3; 200; 200; 200; 4; 6; 3; 6; 200; 3; 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; [hp_X]/mL
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
N-17
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARGININE4 [hp_X]/mL
ASCORBIC ACID3 [hp_X]/mL
BOS TAURUS ADRENAL GLAND200 [hp_X]/mL
BOS TAURUS LYMPH200 [hp_X]/mL
BOS TAURUS THYMUS200 [hp_X]/mL
CYSTINE4 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA6 [hp_X]/mL
PYRIDOXINE HYDROCHLORIDE3 [hp_X]/mL
SELENIUM6 [hp_X]/mL
SUS SCROFA SPLEEN200 [hp_X]/mL
THIAMINE3 [hp_X]/mL
ZINC6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii94ZLA3W45F, PQ6CK8PD0R, M2776SWB29, UGE0WQC19W, 8XEJ88V2T8, 48TCX9A1VT, VB06AV5US8, 68Y4CF58BV, H6241UJ22B, 92AMN5J79Y, X66NSO3N35, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0215-12022-06-06C16284748780-19d75b9d0-c181-f424-e053-dadaa90a57ceN-17
58264-0215-12020-01-31C16284748780-19d75b9d0-c181-f424-e053-dadaa90a57ceN-17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0215-1N-1729.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0215N-17 (ZINC, SELENIUM, BOS TAURUS THYMUS, SUS SCROFA SPLEEN, BOS TAURUS LYMPH, BOS TAURUS ADRENAL GLAND, ARGININE, CYSTINE, ECHINACEA ANGUSTIFOLIA, THIAMINE, PYRIDOXINE HYDROCHLORIDE, AND ASCORBIC ACID) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_a6a13048-b1b4-4a46-acad-d379d4e4b6fb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0215-15826402150129.57 mL in 1 BOTTLE, GLASS (58264-0215-1) 29.57 ml1990-01-010000-00-00NoNoCurrent