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 00:38:21

Label at a glance#

ProductDevrom

Active ingredientBISMUTH SUBGALLATE

Label structure11 sections

Dosage and administration

Adults and children 12 years and over: 1 to 2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours. Children under 12 years: ask a doctor.

Contacts and useful links#

PhoneLabel contact1-800-453-8898

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subgallate 200 mg

Purpose

OTC - PURPOSE SECTION

Internal Deodorant

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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 tablets up to four times daily. Do not exceed 8 tablets in 24 hours. Children under 12 years: ask a doctor.

Other Information

SPL UNCLASSIFIED 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate, microcrystalline cellulose, natural banana flavor. starch, talc, xylitol.

Questions?

OTC - QUESTIONS SECTION

1-800-453-8898

SPL UNCLASSIFIED SECTION

distributed by
The Parthenon Company, Inc.

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Devrom^®
(200 mg bismuth subgallate)

Internal Deodarant
100 chewable tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308757	bismuth subgallate 200 MG Chewable Tablet	PSN	3
1942846	Devrom 200 MG Chewable Tablet	PSN	3
1942846	bismuth subgallate 200 MG Chewable Tablet [Devrom]	SBD	3
308757	bismuth subgallate 200 MG Chewable Tablet	SCD	3
1942846	Devrom 200 MG Chewable Tablet	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BISMUTH CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49309-001-01	2024-01-30	C162847	48780-1	1030e365-1f05-111a-e063-dadaa90a10e2	Devrom ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49309-001-01	Devrom	100 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49309-001	DEVROM (BISMUTH SUBGALLATE) TABLET, CHEWABLE [THE PARTHENON CO., INC.]	3	Current NDC, Legacy NDC, 1 package rows	20241122_6a9408b1-9085-42e6-9104-c6986d5446a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49309-001-01	EA - Each	49309-001	46d4c17d-f75e-4a26-bc51-d87d45859759	1	2024-10-04

Products#

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

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

Devrom
bismuth subgallate
BISMUTH CATION
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49309-001	49309-001-01

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
Name	UNII	Kind
BISMUTH SUBGALLATE	YIW503MI7V	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
XYLITOL	VCQ006KQ1E	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Devrom	BISMUTH SUBGALLATE	The Parthenon Co., Inc.	6a9408b1-9085-42e6-9104-c6986d5446a9	2024-11-12	Warnings	Exact identifier ndc (package): 49309-001-01 ndc (product): 49309-001 ndc11 (package): 49309000101 spl id: 61d82c84-289a-4d83-a8ed-6c026f9edec9 spl set id: 6a9408b1-9085-42e6-9104-c6986d5446a9

Reported adverse events (FAERS/openFDA)#

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