FDA.reportPublic FDA data

Bowel - Digestive Care

Product NDC
55714-2548
11-digit product format
557142548
Labeler code
55714
Product ID
55714-2548_253ff94f-c604-fde3-e063-6294a90ab629
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia.
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-07-01
Substance
ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GINGER; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RADISH; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS
Active strength
15; 15; 15; 15; 15; 15; 6; 6; 15; 15; 15; 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_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], 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], Food Additives [CS], Increased Histamine Release [PE], 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 Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Nut Proteins [EXT], 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIMONY TRISULFIDE15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BAPTISIA TINCTORIA15 [hp_X]/mL
BISMUTH15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
ENGLISH WALNUT6 [hp_X]/mL
GINGER15 [hp_X]/mL
IRIS VERSICOLOR ROOT15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
MAGNESIUM CARBONATE15 [hp_X]/mL
MATRICARIA RECUTITA15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PODOPHYLLUM15 [hp_X]/mL
POTASSIUM DICHROMATE15 [hp_X]/mL
PULSATILLA VULGARIS15 [hp_X]/mL
RADISH15 [hp_X]/mL
SILVER NITRATE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_M]/mL
TOBACCO LEAF15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF79059A38U, S7V92P67HO, 5K1UO2888Y, U015TT5I8H, T7J046YI2B, S003A158SB, 4N9P6CC1DX, 1V3SHR7QB7, C5529G5JPQ, X43D4L3DQC, VSW71SS07I, C88X29Y479, 0E53J927NA, G0R4UBI2ZZ, 27YLU75U4W, 2S713A4VP3, T4423S18FM, I76KB35JEV, EM5RP35463, 95IT3W8JZE

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
55714-2548-0Bowel - Digestive Care15 mL in 1 BOTTLE, GLASSLIQUID153
55714-2548-1Bowel - Digestive Care30 mL in 1 BOTTLE, GLASSLIQUID303
55714-2548-2Bowel - Digestive Care50 mL in 1 BOTTLE, GLASSLIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2548BOWEL - DIGESTIVE CARE (BISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20241027_907f582f-c060-cc60-e053-2a95a90a6f22.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2548-05571425480015 mL in 1 BOTTLE, GLASS (55714-2548-0) 15 ml2019-07-010000-00-00NoNoCurrent
55714-2548-15571425480130 mL in 1 BOTTLE, GLASS (55714-2548-1) 30 ml2019-07-010000-00-00NoNoCurrent
55714-2548-25571425480250 mL in 1 BOTTLE, GLASS (55714-2548-2) 50 ml2019-07-010000-00-00NoNoCurrent