Lower GI and Probiotic Restoration

Product NDC
57955-9971
11-digit product format
579559971
Labeler code
57955
Product ID
57955-9971_09ea8fa3-7e6c-4001-9177-88684728817e
Type
HUMAN OTC DRUG
Nonproprietary name
Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltatum, Sepia and Silicea.
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-03-13
Substance
ACTIVATED CHARCOAL; AETHUSA CYNAPIUM WHOLE; BAPTISIA TINCTORIA ROOT; CAPSICUM; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; COW MILK; GAMBOGE; GARLIC; GRATIOLA OFFICINALIS WHOLE; LACTIC ACID, DL-; MATRICARIA CHAMOMILLA WHOLE; PODOPHYLLUM; RUEHSSIA CUNDURANGO BARK; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED
Active strength
10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lower GI and Probiotic Restoration
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AETHUSA CYNAPIUM WHOLE10 [hp_X]/59mL
GARLIC10 [hp_X]/59mL
BAPTISIA TINCTORIA ROOT10 [hp_X]/59mL
CAPSICUM10 [hp_X]/59mL
ACTIVATED CHARCOAL10 [hp_X]/59mL
MATRICARIA CHAMOMILLA WHOLE10 [hp_X]/59mL
CINCHONA OFFICINALIS BARK10 [hp_X]/59mL
COLLINSONIA CANADENSIS ROOT10 [hp_X]/59mL
CITRULLUS COLOCYNTHIS FRUIT PULP10 [hp_X]/59mL
RUEHSSIA CUNDURANGO BARK10 [hp_X]/59mL
GAMBOGE10 [hp_X]/59mL
GRATIOLA OFFICINALIS WHOLE10 [hp_X]/59mL
COW MILK10 [hp_X]/59mL
LACTIC ACID, DL-10 [hp_X]/59mL
SODIUM CARBONATE10 [hp_X]/59mL
STRYCHNOS NUX-VOMICA SEED10 [hp_X]/59mL
PODOPHYLLUM10 [hp_X]/59mL
SEPIA OFFICINALIS JUICE10 [hp_X]/59mL
SILICON DIOXIDE10 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 19 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M6936L953CInternal UNII lookup
V1V998DC17Internal UNII lookup
5EF0HWI5WUInternal UNII lookup
00UK7646FGInternal UNII lookup
2P3VWU3H10Internal UNII lookup
G0R4UBI2ZZInternal UNII lookup
S003A158SBInternal UNII lookup
O2630F3XDRInternal UNII lookup
23H32AOH17Internal UNII lookup
R23QIR6YBAInternal UNII lookup
7556HJ7587Internal UNII lookup
BDD9991A36Internal UNII lookup
917J3173FTInternal UNII lookup
3B8D35Y7S4Internal UNII lookup
45P3261C7TInternal UNII lookup
269XH13919Internal UNII lookup
2S713A4VP3Internal UNII lookup
QDL83WN8C2Internal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff93Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-9971-2Lower GI and Probiotic Restoration59 mL in 1 BOTTLE, SPRAYLIQUID591

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
ndc (product): 57955-9971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57955-9971-25795599710259 mL in 1 BOTTLE, SPRAY (57955-9971-2) 59 ml2026-03-13NoNoCurrent