FDA.reportPublic FDA data

Tummy Upset

Product NDC
55714-1731
11-digit product format
557141731
Labeler code
55714
Product ID
55714-1731_2d813d91-7ac9-7366-e063-6294a90ad6c2
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla, Echinacea, Iris versicolor, Ruta graveolens, Taraxacum officinale, Aloe, Angelica sinensis radix, Antimonium , Argentum nitricum, Arnica montana, Arsenicum album, Baptisia tinctoria, Bismuthum metallicum, Bryonia, Cinchona officinalis, Graphites, Hydrastis canadensis, Ipecacuanha, Lachesis mutus, Lycopodium clavatum, Myrrha, Natrum carbonicum, Nux vomica, Phosphorus, Pulsatilla, Zingiber officinale.
Dosage form
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
LYCOPODIUM CLAVATUM SPORE; MYRRH; MATRICARIA CHAMOMILLA; SODIUM CARBONATE; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; PHOSPHORUS; ANEMONE PULSATILLA; GINGER; STRYCHNOS NUX-VOMICA SEED; ECHINACEA, UNSPECIFIED
Active strength
15; 15; 6; 15; 6; 6; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage 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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-1731-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-1731-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-1731-10efc9e666f02…f202fb6c5f17…

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
Tummy Upset
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/g
MYRRH15 [hp_X]/g
MATRICARIA CHAMOMILLA6 [hp_X]/g
SODIUM CARBONATE15 [hp_X]/g
IRIS VERSICOLOR ROOT6 [hp_X]/g
RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]/g
TARAXACUM OFFICINALE6 [hp_X]/g
ALOE15 [hp_X]/g
ANGELICA SINENSIS ROOT15 [hp_X]/g
ANTIMONY TRISULFIDE15 [hp_X]/g
SILVER NITRATE15 [hp_X]/g
ARNICA MONTANA15 [hp_X]/g
ARSENIC TRIOXIDE15 [hp_X]/g
BAPTISIA TINCTORIA15 [hp_X]/g
BISMUTH15 [hp_X]/g
BRYONIA ALBA ROOT15 [hp_X]/g
CINCHONA OFFICINALIS BARK15 [hp_X]/g
GRAPHITE15 [hp_X]/g
GOLDENSEAL15 [hp_X]/g
IPECAC15 [hp_X]/g
LACHESIS MUTA VENOM15 [hp_X]/g
PHOSPHORUS15 [hp_X]/g
ANEMONE PULSATILLA15 [hp_X]/g
GINGER15 [hp_X]/g
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/g
ECHINACEA, UNSPECIFIED6 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 26 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C88X29Y479Internal UNII lookup
JC71GJ1F3LInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
45P3261C7TInternal UNII lookup
X43D4L3DQCInternal UNII lookup
N94C2U587SInternal UNII lookup
39981FM375Internal UNII lookup
V5VD430YW9Internal UNII lookup
B66F4574UGInternal UNII lookup
F79059A38UInternal UNII lookup
95IT3W8JZEInternal UNII lookup
O80TY208ZWInternal UNII lookup
S7V92P67HOInternal UNII lookup
5K1UO2888YInternal UNII lookup
U015TT5I8HInternal UNII lookup
T7J046YI2BInternal UNII lookup
S003A158SBInternal UNII lookup
4QQN74LH4OInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
62I3C8233LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9dc307a2-4aa1-b02a-e053-2995a90a1788Available 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
55714-1731-1Tummy Upset28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1731TUMMY UPSET (CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250209_9dc307a2-4aa1-b02a-e053-2995a90a1788.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
Tummy UpsetCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9dc307a2-4aa1-b02a-e053-2995a90a17882025-02-06WarningsExact identifier
ndc (product): 55714-1731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-1731-15571417310128 g in 1 BOTTLE, GLASS (55714-1731-1) 28 g2019-01-010000-00-00NoNoCurrent