FDA.reportPublic FDA data

Devrom

Manufacturer
The Parthenon Co., Inc.
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:34

Label at a glance#

ProductDevrom
Active ingredientBISMUTH SUBGALLATE
Label structure11 sections

Dosage and administration

Adults and children 12 years and over: 1 to 2 capsules up to four times daily or as directed by physician. Do not exceed 8 capsules in 24 hours. Children under 12 years: ask a doctor.

Storage and handling

This product cannot be expected to be effective in the reduction of odor due to faulty personal hygiene. Does not contain gluten, lactose, or salicylates. Store in a cool, dry place. Do not use if outer safety seal or printed inner safety seal is broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subgallate 200 mg

Purpose

OTC - PURPOSE SECTION

Internal Deodorant

INDICATIONS & USAGE SECTION

Use for eliminating or reducing odor from flatulence (gas) and stool (feces).

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast-feeding, ask a health professional before use.
  • When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
  • In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over: 1 to 2 capsules up to four times daily or as directed by physician.
  • Do not exceed 8 capsules in 24 hours.
  • Children under 12 years: ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

  • This product cannot be expected to be effective in the reduction of odor due to faulty personal hygiene.
  • Does not contain gluten, lactose, or salicylates.
  • Store in a cool, dry place. Do not use if outer safety seal or printed inner safety seal is broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

microcrystalline cellulose, maltodextrine, croscarmellose, silica, magnesium stearate.

Questions?

OTC - QUESTIONS SECTION

1-800-453-8898

SPL UNCLASSIFIED SECTION

Manufactured for and distributed by
The Parthenon Company, Inc.

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Devrom®
(200 mg bismuth subgallate)

Internal Deodorant
100 capsules

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283720bismuth subgallate 200 MG Oral CapsulePSN3
2106743Devrom 200 MG Oral CapsulePSN3
2106743bismuth subgallate 200 MG Oral Capsule [Devrom]SBD3
283720bismuth subgallate 200 MG Oral CapsuleSCD3
2106743Devrom 200 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49309-002-012024-01-30C16284748780-11030e365-042f-111a-e063-dadaa90a10e2Devrom ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49309-002-01Devrom100 in 1 BOTTLE, PLASTICCAPSULE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49309-002DEVROM (BISMUTH SUBGALLATE) CAPSULE [THE PARTHENON CO., INC.]3Current NDC, Legacy NDC, 1 package rows20241122_fb6ad16b-caac-4a63-a10e-99808a6a83e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49309-002-01EA - Each49309-0026b0656b6-d633-437c-9dcb-661241502da012024-10-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49309-00249309-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBGALLATEYIW503MI7VACTIB
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MALTODEXTRIN7CVR7L4A2DIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

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
DevromBISMUTH SUBGALLATEThe Parthenon Co., Inc.fb6ad16b-caac-4a63-a10e-99808a6a83e72024-11-12WarningsExact identifier
ndc (package): 49309-002-01
ndc (product): 49309-002
ndc11 (package): 49309000201
spl id: 6d691cdb-1787-413c-84fc-5f030db289f9
spl set id: fb6ad16b-caac-4a63-a10e-99808a6a83e7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.