FDA.reportPublic FDA data

GBLV HP

Product NDC
43406-0613
11-digit product format
434060613
Labeler code
43406
Product ID
43406-0613_80fed459-9130-46b5-906d-b6d90be133ca
Type
HUMAN OTC DRUG
Nonproprietary name
Atropa Belladonna, Berberis Vulgaris Root Bark, Milk Thistle, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Dioscorea Villosa Tuber, Goldenseal, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-Vomica Seed, Phosphorus, Anemone Pulsatilla, Veratrum Album Root
Dosage form
LIQUID
Route
ORAL
Labeler
Natural Creations, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-06-01
Substance
ANEMONE PULSATILLA; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage 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
GBLV HP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANEMONE PULSATILLA30 [hp_C]/mL
ATROPA BELLADONNA30 [hp_C]/mL
BERBERIS VULGARIS ROOT BARK30 [hp_C]/mL
CHELIDONIUM MAJUS30 [hp_C]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP30 [hp_C]/mL
DIOSCOREA VILLOSA TUBER30 [hp_C]/mL
GOLDENSEAL30 [hp_C]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_C]/mL
MILK THISTLE30 [hp_C]/mL
PHOSPHORUS30 [hp_C]/mL
SODIUM SULFATE30 [hp_C]/mL
STRYCHNOS NUX-VOMICA SEED30 [hp_C]/mL
VERATRUM ALBUM ROOT30 [hp_C]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI76KB35JEV, WQZ3G9PF0H, 1TH8Q20J0U, 7E889U5RNN, 23H32AOH17, IWY3IWX2G8, ZW3Z11D0JV, C88X29Y479, U946SH95EE, 27YLU75U4W, 0YPR65R21J, 269XH13919, QNS6W5US1Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0613-12022-03-03C16284748780-1d6a99b39-ba2e-a426-e053-dadaa90af4c2GBLV HP
43406-0613-12022-01-28C16284748780-1d6a99b39-ba2e-a426-e053-dadaa90af4c2GBLV HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0613-1GBLV HP30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0613GBLV HP (ATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, MILK THISTLE, CHELIDONIUM MAJUS, CITRULLUS COLOCYNTHIS FRUIT PULP, DIOSCOREA VILLOSA TUBER, GOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, VERATRUM ALBUM ROOT) LIQUID [NATURAL CREATIONS, INC.]4Current NDC, Legacy NDC, 1 package rows20220304_cff4d830-6696-4cde-9cd7-4ce55e28b54b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43406-0613-14340606130130 mL in 1 BOTTLE, DROPPER (43406-0613-1) 30 ml2016-06-010000-00-00NoNoCurrent