A-35

Product NDC
58264-0327
Requested package NDC
58264-0327-1
11-digit product format
582640327
Labeler code
58264
Product ID
58264-0327_2b50d581-e5e9-638a-e063-6294a90a8ddc
Type
HUMAN OTC DRUG
Nonproprietary name
Bos taurus adrenal gland, Onion, Garlic, Amanita muscaria fruiting body, Avena sativa flowering top, Activated charcoal, Arabica coffee bean, Histamine dihydrochloride, Hydrangea arborescens root, Skim milk, Corn silk, and Elymus repens whole
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; BOS TAURUS ADRENAL GLAND; CORN SILK; ELYMUS REPENS WHOLE; GARLIC; HISTAMINE DIHYDROCHLORIDE; HYDRANGEA ARBORESCENS ROOT; ONION; SKIM MILK
Active strength
30; 30; 30; 30; 6; 30; 30; 30; 30; 4; 30; 30 [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
Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable 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 dateSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
A-35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL30 [hp_X]/mL
ARABICA COFFEE BEAN30 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE30 [hp_X]/mL
HYDRANGEA ARBORESCENS ROOT30 [hp_X]/mL
SKIM MILK6 [hp_X]/mL
CORN SILK30 [hp_X]/mL
ELYMUS REPENS WHOLE30 [hp_X]/mL
BOS TAURUS ADRENAL GLAND30 [hp_X]/mL
ONION30 [hp_X]/mL
GARLIC4 [hp_X]/mL
AMANITA MUSCARIA FRUITING BODY30 [hp_X]/mL
AVENA SATIVA FLOWERING TOP30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2P3VWU3H10Internal UNII lookup
3SW678MX72Internal UNII lookup
3POA0Q644UInternal UNII lookup
SFK828Q2DEInternal UNII lookup
6A001Y4M5AInternal UNII lookup
7D3VB244UXInternal UNII lookup
BE5076899XInternal UNII lookup
M2776SWB29Internal UNII lookup
492225Q21HInternal UNII lookup
V1V998DC17Internal UNII lookup
DIF093I037Internal UNII lookup
MA9CQJ3F7FInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee0c1801-8303-49ed-bf50-4109b812f76cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0327-12022-05-30C16284748780-19d75b9cf-f9c2-f424-e053-dadaa90a57ceA-35
58264-0327-12020-01-31C16284748780-19d75b9cf-f9c2-f424-e053-dadaa90a57ceA-35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0327-1A-3529.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0327A-35 (BOS TAURUS ADRENAL GLAND, ONION, GARLIC, AMANITA MUSCARIA FRUITING BODY, AVENA SATIVA FLOWERING TOP, ACTIVATED CHARCOAL, ARABICA COFFEE BEAN, HISTAMINE DIHYDROCHLORIDE, HYDRANGEA ARBORESCENS ROOT, SKIM MILK, CORN SILK, AND ELYMUS REPENS WHOLE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_ee0c1801-8303-49ed-bf50-4109b812f76c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A-35BOS TAURUS ADRENAL GLAND, ONION, GARLIC, AMANITA MUSCARIA FRUITING BODY, AVENA SATIVA FLOWERING TOP, ACTIVATED CHARCOAL, ARABICA COFFEE BEAN, HISTAMINE DIHYDROCHLORIDE, HYDRANGEA ARBORESCENS ROOT, SKIM MILK, CORN SILK, AND ELYMUS REPENS WHOLEDNA Labs, Inc.ee0c1801-8303-49ed-bf50-4109b812f76c2025-01-09WarningsExact identifier
ndc (package): 58264-0327-1
ndc (product): 58264-0327
ndc11 (package): 58264032701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0327-15826403270129.57 mL in 1 BOTTLE, GLASS (58264-0327-1) 29.57 ml1990-01-010000-00-00NoNoCurrent