Peptic Relief

Product NDC
0536-1021
11-digit product format
005361021
Labeler code
0536
Product ID
0536-1021_429ee2d1-2c5c-4967-bf7d-0e1e8ebd2768
Type
HUMAN OTC DRUG
Nonproprietary name
Peptic Relief
Dosage form
TABLET
Route
ORAL
Labeler
Rugby Laboratories
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-20
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-1021DDiscontinued by firm2026-08-11
excluded packagepackage0536-10210536-1021-07DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-1021-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1021-07f5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1021-07EA - Each0536-1021e7dbe18c-dddc-40aa-a591-11d962d7affa12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1PEPTIC RELIEF TABLET [RUGBY LABORATORIES]1
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEPEPTIC RELIEF TABLET [RUGBY LABORATORIES]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPEPTIC RELIEF TABLET [RUGBY LABORATORIES]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPEPTIC RELIEF TABLET [RUGBY LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PEPTIC RELIEF TABLET [RUGBY LABORATORIES]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APEPTIC RELIEF TABLET [RUGBY LABORATORIES]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPEPTIC RELIEF TABLET [RUGBY LABORATORIES]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPEPTIC RELIEF TABLET [RUGBY LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1021PEPTIC RELIEF TABLET [RUGBY LABORATORIES]6Legacy NDC20241206_713a580e-9ddb-44cd-8989-7411b7fd647c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1021-070053610210730 TABLET in 1 BOTTLE (0536-1021-07) 30 tablet2014-02-200000-00-00NoNoCurrent