Gluten Mix

Product NDC
63083-1027
11-digit product format
630831027
Labeler code
63083
Product ID
63083-1027_b76624a0-7583-4219-bc3b-2d87c2bd1f79
Type
HUMAN OTC DRUG
Nonproprietary name
Gluten Mix
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
WHEAT GLUTEN
Active strength
6 [hp_X]/59mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gluten Mix
Brand name suffix
1027
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHEAT GLUTEN6 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1534K8653J

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-1027-22026-01-09C16284748780-11030e365-2f65-111a-e063-dadaa90a10e2AGLUT
63083-1027-22026-01-09C16284748780-11030e365-2f65-111a-e063-dadaa90a10e2AGLUT
63083-1027-22024-01-30C16284748780-11030e365-2f65-111a-e063-dadaa90a10e2AGLUT
63083-1027-22024-01-30C16284748780-11030e365-2f65-111a-e063-dadaa90a10e2AGLUT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-1027-2Gluten Mix102759 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-1027GLUTEN MIX 1027 (GLUTEN MIX) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220201_b592764a-0923-4994-a3af-566e5f9ce060.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-1027-26308310270259 mL in 1 BOTTLE, DROPPER (63083-1027-2) 59 ml1985-08-150000-00-00NoNoCurrent