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
ACTIVATED CHARCOAL12 [hp_X]/mL
BISMUTH SUBNITRATE200 [hp_C]/mL
CALCIUM SULFATE ANHYDROUS200 [hp_C]/mL
CARBO ANIMALIS12 [hp_X]/mL
CINCHONA OFFICINALIS BARK200 [hp_C]/mL
GOLDENSEAL12 [hp_X]/mL
ORNITHOGALUM UMBELLATUM WHOLE12 [hp_X]/mL
RANCID BEEF200 [hp_C]/mL
SILICON DIOXIDE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED200 [hp_C]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, H19J064BA5, E934B3V59H, 279O8I0433, S003A158SB, ZW3Z11D0JV, 9NS3M2Y78S, 29SUH5R3HU, ETJ7Z6XBU4, 269XH13919

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0253-12023-09-11C16284748780-1ba0f9c33-1c04-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0253-12023-01-30C16284748780-1ba0f9c33-1c04-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0253-12021-03-02C16284748780-1ba0f9c33-1c04-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0253-12021-01-29C16284748780-1ba0f9c33-1c04-a910-e053-dadaa90a0b85DRUG 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

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