A-14

Product NDC
58264-0306
11-digit product format
582640306
Labeler code
58264
Product ID
58264-0306_2b4dc94d-fc3a-c966-e063-6294a90ab3d7
Type
HUMAN OTC DRUG
Nonproprietary name
Cod, Unspecified, Flounder, Unspecified, Halibut, Unspecified, Mackerel, Unspecified, Tuna, Unspecified, and Salmon, Unspecified
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
COD, UNSPECIFIED; FLOUNDER, UNSPECIFIED; HALIBUT, UNSPECIFIED; MACKEREL, UNSPECIFIED; SALMON, UNSPECIFIED; TUNA, UNSPECIFIED
Active strength
30; 30; 30; 30; 30; 30 [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], 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], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [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-14
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COD, UNSPECIFIED30 [hp_X]/mL
FLOUNDER, UNSPECIFIED30 [hp_X]/mL
HALIBUT, UNSPECIFIED30 [hp_X]/mL
MACKEREL, UNSPECIFIED30 [hp_X]/mL
SALMON, UNSPECIFIED30 [hp_X]/mL
TUNA, UNSPECIFIED30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8D6Q5LNG3D, T197LO581X, T5G0QPU3E4, CYO6K3VM7F, 6122W2M0GB, V2T3IHT3E2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0306-12022-05-30C16284748780-19d75b9d0-50a7-f424-e053-dadaa90a57ceA-14
58264-0306-12020-01-31C16284748780-19d75b9d0-50a7-f424-e053-dadaa90a57ceA-14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0306-1A-1429.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0306A-14 (COD, UNSPECIFIED, FLOUNDER, UNSPECIFIED, HALIBUT, UNSPECIFIED, MACKEREL, UNSPECIFIED, TUNA, UNSPECIFIED, AND SALMON, UNSPECIFIED) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_0cae2418-2f77-4c1e-848c-cea9e5ebdb23.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0306-15826403060129.57 mL in 1 BOTTLE, GLASS (58264-0306-1) 29.57 ml1990-01-010000-00-00NoNoCurrent