FDA.reportPublic FDA data

Stomach Relief

Product NDC
51013-321
11-digit product format
510130321
Labeler code
51013
Product ID
51013-321_841fb60d-9e76-4a46-8905-7de3f25b6788
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-11-28
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
Stomach 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
01a4782f-93af-4d30-8ca3-7b39c272f60eAvailable 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-321-54Stomach Relief2 in 1 POUCHTABLET, CHEWABLE21
51013-321-54Stomach Relief15 in 1 CARTONTABLET, CHEWABLE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-321STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]1Current NDC, Legacy NDC, 2 package rows20171128_01a4782f-93af-4d30-8ca3-7b39c272f60e.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
Stomach ReliefBISMUTH SUBSALICYLATEPuraCap Pharmaceutical LLC01a4782f-93af-4d30-8ca3-7b39c272f60e2017-11-28WarningsExact identifier
ndc (product): 51013-321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN01a4782f-93af-4d30-8ca3-7b39c272f60e1
308761bismuth subsalicylate 262 MG Chewable TabletSCD01a4782f-93af-4d30-8ca3-7b39c272f60e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-321-545101303215415 POUCH in 1 CARTON (51013-321-54) / 2 TABLET, CHEWABLE in 1 POUCH15 pouch2017-11-280000-00-00NoNoCurrent