FDA.reportPublic FDA data

Digest Ease

Product NDC
76472-7007
Requested package NDC
76472-7007-2
11-digit product format
764727007
Labeler code
76472
Product ID
76472-7007_594f5553-dd2e-4799-e063-6394a90acee0
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis vulgaris 3C, Carduus marianus 3C, Chelidonium majus 3C, Nux vomica 5C, Robinia pseudoacacia 3C, Taraxacum officinale 3C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
ROBINIA PSEUDOACACIA BARK; TARAXACUM OFFICINALE WHOLE; CHELIDONIUM MAJUS WHOLE; STRYCHNOS NUX-VOMICA SEED; BERBERIS VULGARIS ROOT BARK; SILYBUM MARIANUM SEED
Active strength
.1; .1; .1; .1; .1; .1 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Digest Ease
Brand name suffix
Difficult Digestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROBINIA PSEUDOACACIA BARK.1 mg/100mL
TARAXACUM OFFICINALE WHOLE.1 mg/100mL
CHELIDONIUM MAJUS WHOLE.1 mg/100mL
STRYCHNOS NUX-VOMICA SEED.1 mg/100mL
BERBERIS VULGARIS ROOT BARK.1 mg/100mL
SILYBUM MARIANUM SEED.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7TPC058OWYInternal UNII lookup
7C42E2D7B0Internal UNII lookup
7E889U5RNNInternal UNII lookup
269XH13919Internal UNII lookup
1TH8Q20J0UInternal UNII lookup
U946SH95EEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54ffc26a-5b77-7b7d-e063-6394a90aabf4Available on FDA.report

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
Digest Ease Difficult DigestionBERBERIS VULGARIS 3C, CARDUUS MARIANUS 3C, CHELIDONIUM MAJUS 3C, NUX VOMICA 5C, ROBINIA PSEUDOACACIA 3C, TARAXACUM OFFICINALE 3CSEVENE USA54ffc26a-5b77-7b7d-e063-6394a90aabf42026-08-18WarningsExact identifier
ndc (package): 76472-7007-2
ndc (product): 76472-7007
ndc11 (package): 76472700702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7007-2764727007021 BOTTLE, SPRAY in 1 BOX (76472-7007-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7007-1) 2026-08-19NoNoCurrent