FDA.reportPublic FDA data

Bowel-Digestive Care

Product NDC
55714-1534
11-digit product format
557141534
Labeler code
55714
Product ID
55714-1534_2cc85881-a8bd-15f4-e063-6394a90a88a1
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Juglans regia, Antimonium crudum, Argentum nitricum, Arsenicum album, Baptisia tinctoria, Bismuthum metallicum, Bryonia, Chamomilla, Cinchona officinalis, Iris versicolor, Kali bichromicum, Lachesis mutus, Lycopodium clavatum, Magnesia carbonica, Nux vomica, Phosphorus, Podophyllum peltatum, Pulsatilla, Raphanus sativus, Rhus toxicodendron, Tabacum, Verbascum thapsus, Zingiber officinale
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
ANEMONE PULSATILLA; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; GINGER; IRIS VERSICOLOR ROOT; JUGLANS REGIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA CHAMOMILLA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; RADISH; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS
Active strength
15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant 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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-1534-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-1534-10efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Bowel-Digestive Care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GINGER15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ANTIMONY TRISULFIDE15 [hp_X]/mL
SILVER NITRATE15 [hp_X]/mL
BISMUTH15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
MATRICARIA CHAMOMILLA6 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
IRIS VERSICOLOR ROOT15 [hp_X]/mL
POTASSIUM DICHROMATE6 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
MAGNESIUM CARBONATE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
PODOPHYLLUM15 [hp_X]/mL
ANEMONE PULSATILLA15 [hp_X]/mL
RADISH15 [hp_X]/mL
TOBACCO LEAF15 [hp_X]/mL
BAPTISIA TINCTORIA ROOT15 [hp_X]/mL
JUGLANS REGIA LEAF15 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C5529G5JPQInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
S7V92P67HOInternal UNII lookup
F79059A38UInternal UNII lookup
95IT3W8JZEInternal UNII lookup
U015TT5I8HInternal UNII lookup
T7J046YI2BInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
S003A158SBInternal UNII lookup
X43D4L3DQCInternal UNII lookup
T4423S18FMInternal UNII lookup
VSW71SS07IInternal UNII lookup
C88X29Y479Internal UNII lookup
0E53J927NAInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
6IO182RP7AInternal UNII lookup
2S713A4VP3Internal UNII lookup
I76KB35JEVInternal UNII lookup
EM5RP35463Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d60d399-6f63-5842-e053-2995a90a7cf7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1534-1Bowel-Digestive Care30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1534BOWEL-DIGESTIVE CARE (ECHINACEA, JUGLANS REGIA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, IRIS VERSICOLOR, KALI BICHROMICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RAPHANUS SATIVUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM THAPSUS, ZINGIBER OFFICINALE) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250130_9d60d399-6f63-5842-e053-2995a90a7cf7.zip

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
Bowel-Digestive CareECHINACEA, JUGLANS REGIA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, IRIS VERSICOLOR, KALI BICHROMICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RAPHANUS SATIVUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM THAPSUS, ZINGIBER OFFICINALENewton Laboratories, Inc.9d60d399-6f63-5842-e053-2995a90a7cf72025-01-28WarningsExact identifier
ndc (product): 55714-1534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-1534-15571415340130 mL in 1 BOTTLE, GLASS (55714-1534-1) 30 ml2019-01-010000-00-00NoNoCurrent