FDA.reportPublic FDA data

Devrom

Product NDC
49309-002
11-digit product format
493090002
Labeler code
49309
Product ID
49309-002_6d691cdb-1787-413c-84fc-5f030db289f9
Type
HUMAN OTC DRUG
Nonproprietary name
bismuth subgallate
Dosage form
CAPSULE
Route
ORAL
Labeler
The Parthenon Co., Inc.
Application
M026
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-01
Substance
BISMUTH SUBGALLATE
Active strength
200 mg/1
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Devrom
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBGALLATE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YIW503MI7VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283720Internal RxNorm lookup
2106743Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb6ad16b-caac-4a63-a10e-99808a6a83e7Available on FDA.report

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 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

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

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Genital wart removal onitmentSALICYLIC ACID 40%Guangxi Keyun E-commerce Co., Ltd.4f8f0131-ed5f-027d-e063-6294a90a276c2026-04-16WarningsExact identifier
application number: M026
Milia removerSALICYLIC ACIDGuangxi Keyun E-commerce Co., Ltd.4d6fd754-bfa0-d810-e063-6394a90a87422026-03-20WarningsExact identifier
application number: M026
Exchange Select Mens Extra Fresh DeodorantALUMINUM SESQUICHLOROHYDRATELongway Technology(Guangzhou) Co., Ltd42f2aa95-cd85-78fd-e063-6294a90ab20f2025-11-18WarningsExact identifier
application number: M026
Exchange Select Shower Fresh DeodorantALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLYLongway Technology(Guangzhou) Co., Ltd42f2d0fd-e8d8-9977-e063-6294a90a01e12025-11-18WarningsExact identifier
application number: M026
Exchange Select Powder Fresh DeodorantALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLYLongway Technology(Guangzhou)Co., Ltd.42f2c127-98d0-a7b8-e063-6394a90abb402025-11-06WarningsExact identifier
application number: M026
Exchange Select Powder Fresh DeodorantALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLYArmy & Air Force Exchange Service42c7acb4-389b-df8a-e063-6394a90a875e2025-11-04WarningsExact identifier
application number: M026
Exchange Select Mens Extra Fresh DeodorantALUMINUM SESQUICHLOROHYDRATEArmy & Air Force Exchange Service6dea03c4-34fa-428b-9a19-701a264d1cb02025-11-04WarningsExact identifier
application number: M026
Exchange Select Shower Fresh DeodorantALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLYArmy & Air Force Exchange Service3bc56f59-de0d-417f-ad54-9e5976c60f542025-11-03WarningsExact identifier
application number: M026
DevromBISMUTH SUBGALLATEThe Parthenon Co., Inc.6a9408b1-9085-42e6-9104-c6986d5446a92024-11-12WarningsExact identifier
application number: M026
DevromBISMUTH SUBGALLATEThe Parthenon Co., Inc.fb6ad16b-caac-4a63-a10e-99808a6a83e72024-11-12WarningsExact identifier
application number: M026
ndc (product): 49309-002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283720bismuth subgallate 200 MG Oral CapsulePSNfb6ad16b-caac-4a63-a10e-99808a6a83e73
2106743Devrom 200 MG Oral CapsulePSNfb6ad16b-caac-4a63-a10e-99808a6a83e73
2106743bismuth subgallate 200 MG Oral Capsule [Devrom]SBDfb6ad16b-caac-4a63-a10e-99808a6a83e73
283720bismuth subgallate 200 MG Oral CapsuleSCDfb6ad16b-caac-4a63-a10e-99808a6a83e73
2106743Devrom 200 MG Oral CapsuleSYfb6ad16b-caac-4a63-a10e-99808a6a83e73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49309-002-0149309000201100 CAPSULE in 1 BOTTLE, PLASTIC (49309-002-01) 100 capsule2018-12-010000-00-00NoNoCurrent