A-18

Product NDC
58264-0310
Requested package NDC
58264-0310-1
11-digit product format
582640310
Labeler code
58264
Product ID
58264-0310_2b50ca28-f7a4-9231-e063-6394a90aae1e
Type
HUMAN OTC DRUG
Nonproprietary name
Ceiba Pentandra Seed, Powdered Cellulose, and Bombyx Mori Fiber
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
CEIBA PENTANDRA SEED; POWDERED CELLULOSE; BOMBYX MORI FIBER
Active strength
30; 30; 30 [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], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC], Silk [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…

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
A-18
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEIBA PENTANDRA SEED30 [hp_X]/mL
POWDERED CELLULOSE30 [hp_X]/mL
BOMBYX MORI FIBER30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
72NWF32VZ6Internal UNII lookup
SMD1X3XO9MInternal UNII lookup
6LK42KUV6WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba92d784-26be-46da-8efe-ec121fb64b8dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0310-12022-05-30C16284748780-19d75b9cf-f944-f424-e053-dadaa90a57ceA-18
58264-0310-12020-01-31C16284748780-19d75b9cf-f944-f424-e053-dadaa90a57ceA-18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0310-1A-1829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0310A-18 (CEIBA PENTANDRA SEED, POWDERED CELLULOSE, AND BOMBYX MORI FIBER) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_ba92d784-26be-46da-8efe-ec121fb64b8d.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-18CEIBA PENTANDRA SEED, POWDERED CELLULOSE, AND BOMBYX MORI FIBERDNA Labs, Inc.ba92d784-26be-46da-8efe-ec121fb64b8d2025-01-09WarningsExact identifier
ndc (package): 58264-0310-1
ndc (product): 58264-0310
ndc11 (package): 58264031001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0310-15826403100129.57 mL in 1 BOTTLE, GLASS (58264-0310-1) 29.57 ml1990-01-010000-00-00NoNoCurrent