FDA.reportPublic FDA data

Pepto Relief

Product NDC
54738-102
11-digit product format
547380102
Labeler code
54738
Product ID
54738-102_5cc53a8f-4daa-7cff-e053-2991aa0a383b
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 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
Pepto Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308761Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6f383b4-47f9-4837-93e2-2ca114fb20b9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-102-30Pepto Relief30 in 1 BOTTLETABLET, CHEWABLE302
54738-102-48Pepto Relief48 in 1 BOTTLETABLET, CHEWABLE482

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-102-30EA - Each54738-10246da8983-4f4e-421f-958d-fb46c3679e8712017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-102PEPTO RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC]2Current NDC, Legacy NDC, 2 package rows20171030_a6f383b4-47f9-4837-93e2-2ca114fb20b9.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
Pepto ReliefBISMUTH SUBSALICYLATERichmond Pharmaceuticals, Inca6f383b4-47f9-4837-93e2-2ca114fb20b92017-10-30WarningsExact identifier
ndc (product): 54738-102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSNa6f383b4-47f9-4837-93e2-2ca114fb20b92
308761bismuth subsalicylate 262 MG Chewable TabletSCDa6f383b4-47f9-4837-93e2-2ca114fb20b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54738-102-305473801023030 TABLET, CHEWABLE in 1 BOTTLE (54738-102-30) 2015-06-010000-00-00NoNoCurrent
54738-102-485473801024848 TABLET, CHEWABLE in 1 BOTTLE (54738-102-48) 2015-06-010000-00-00NoNoCurrent