A-18

Product NDC
58264-0310
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
BOMBYX MORI FIBER; CEIBA PENTANDRA SEED; POWDERED CELLULOSE
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

Additional Listing Data#

Finished product
Yes
Brand name base
A-18
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6LK42KUV6W, 72NWF32VZ6, SMD1X3XO9M

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

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