Stomach Distress

Product NDC
50845-0253
11-digit product format
508450253
Labeler code
50845
Product ID
50845-0253_a9bf700b-7627-4df6-8a49-84355f350b59
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuthum Subnitricum, Calcarea Sulphurica, Carbo Animalis, Carbo Vegetabilis, Cinchona Officinalis, Hydrastis Canadensis, Nux Vomica, Ornithogalum Umbellatum, Pyrogenium, Silicea,
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-04-12
Substance
ACTIVATED CHARCOAL; BISMUTH SUBNITRATE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; CINCHONA OFFICINALIS BARK; GOLDENSEAL; ORNITHOGALUM UMBELLATUM WHOLE; RANCID BEEF; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED
Active strength
12; 200; 200; 12; 200; 12; 12; 200; 12; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL
Pharmacologic classes
Allergens [CS], Bismuth [CS], Bismuth [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage 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
Stomach Distress
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBNITRATE12 [hp_X]/mL
CALCIUM SULFATE ANHYDROUS200 [hp_C]/mL
CARBO ANIMALIS200 [hp_C]/mL
ACTIVATED CHARCOAL12 [hp_X]/mL
CINCHONA OFFICINALIS BARK200 [hp_C]/mL
GOLDENSEAL12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
ORNITHOGALUM UMBELLATUM WHOLE200 [hp_C]/mL
RANCID BEEF12 [hp_X]/mL
SILICON DIOXIDE200 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H19J064BA5Internal UNII lookup
E934B3V59HInternal UNII lookup
279O8I0433Internal UNII lookup
2P3VWU3H10Internal UNII lookup
S003A158SBInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
269XH13919Internal UNII lookup
9NS3M2Y78SInternal UNII lookup
29SUH5R3HUInternal 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
4c764fbe-2fbf-4f06-9ad5-824373c6929aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-09-11DRUG FACTS:
2023-01-30DRUG FACTS:
2021-03-02DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0253-1Stomach Distress30 mL in 1 BOTTLE, SPRAYSPRAY304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0253STOMACH DISTRESS (BISMUTHUM SUBNITRICUM, CALCAREA SULPHURICA, CARBO ANIMALIS, CARBO VEGETABILIS, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, NUX VOMICA, ORNITHOGALUM UMBELLATUM, PYROGENIUM, SILICEA,) SPRAY [LIDDELL LABORATORIES, INC.]4Current NDC, Legacy NDC, 1 package rows20230912_4c764fbe-2fbf-4f06-9ad5-824373c6929a.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
Stomach DistressBISMUTHUM SUBNITRICUM, CALCAREA SULPHURICA, CARBO ANIMALIS, CARBO VEGETABILIS, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, NUX VOMICA, ORNITHOGALUM UMBELLATUM, PYROGENIUM, SILICEA,Liddell Laboratories, Inc.4c764fbe-2fbf-4f06-9ad5-824373c6929a2023-09-11WarningsExact identifier
ndc (product): 50845-0253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0253-15084502530130 mL in 1 BOTTLE, SPRAY (50845-0253-1) 30 ml2019-04-120000-00-00NoNoCurrent