A-16

Product NDC
58264-0308
11-digit product format
582640308
Labeler code
58264
Product ID
58264-0308_2b50ca28-f7a3-9231-e063-6394a90aae1e
Type
HUMAN OTC DRUG
Nonproprietary name
Barley, Corn, Oat, and Wheat
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
BARLEY; CORN; OAT; WHEAT
Active strength
30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Increased Histamine Release [PE], 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 Food Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
A-16
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BARLEY30 [hp_X]/mL
CORN30 [hp_X]/mL
OAT30 [hp_X]/mL
WHEAT30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PWM7YLI7R, 0N8672707O, Z6J799EAJK, 4J2I0SN84Y

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0308-12022-05-30C16284748780-19d75b9d0-7d26-f424-e053-dadaa90a57ceA-16
58264-0308-12020-01-31C16284748780-19d75b9d0-7d26-f424-e053-dadaa90a57ceA-16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0308-1A-1629.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0308A-16 (BARLEY, CORN, OAT, AND WHEAT) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_bfa29f3b-b067-4ee7-bfd1-e387180eabef.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0308-15826403080129.57 mL in 1 BOTTLE, GLASS (58264-0308-1) 29.57 ml1990-01-010000-00-00NoNoCurrent