A-4

Product NDC
58264-0296
11-digit product format
582640296
Labeler code
58264
Product ID
58264-0296_2b50847e-e715-d4c0-e063-6394a90af73b
Type
HUMAN OTC DRUG
Nonproprietary name
COCOA, COFFEE BEAN, and TEA LEAF
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
COCOA; COFFEE BEAN; TEA LEAF
Active strength
30; 30; 30 [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], Plant Proteins [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-4
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA30 [hp_X]/mL
COFFEE BEAN30 [hp_X]/mL
TEA LEAF30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9108TZ9KG, JFH385Y744, GH42T47V24

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0296-12022-05-30C16284748780-19d75b9d0-7d1a-f424-e053-dadaa90a57ceA-4
58264-0296-12020-01-31C16284748780-19d75b9d0-7d1a-f424-e053-dadaa90a57ceA-4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0296-1A-429.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0296A-4 (COCOA, COFFEE BEAN, AND TEA LEAF) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_e06600fd-ad68-4d88-8323-daa3bee68f90.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0296-15826402960129.57 mL in 1 BOTTLE, GLASS (58264-0296-1) 29.57 ml1990-01-010000-00-00NoNoCurrent