PINK BISMUTH

Product NDC
0536-1810
11-digit product format
005361810
Labeler code
0536
Product ID
0536-1810_7e066ff9-b0aa-2a57-e053-2991aa0a02e9
Type
HUMAN OTC DRUG
Nonproprietary name
bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-04-01
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/15mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct0536-1810DDiscontinued by firm2026-08-17
excluded packagepackage0536-18100536-1810-59DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage0536-1810-59d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1810-59f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-1810-592ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-1810-59a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-1810-59cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-1810-59cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-1810-59302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-1810-59ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-1810-590efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-1810-59ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-1810-59367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-1810-59557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1810-59ML - Milliliter0536-1810ca1acb9c-e6c8-4d9c-a74b-2fc222877aa012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
BISMUTH SUBSALICYLATEACTIVE MOIETY62TEY51RR1PINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYPPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPINK BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [RUGBY LABORATORIES, INC.]1