PINK BISMUTH

Product NDC
57896-392
11-digit product format
578960392
Labeler code
57896
Product ID
57896-392_604fe4c7-b151-1ae3-e053-2991aa0ac615
Type
HUMAN OTC DRUG
Nonproprietary name
bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2000-01-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57896-392DDiscontinued by firm2026-10-15
excluded packagepackage57896-39257896-392-08DDiscontinued by firm2026-10-15
excluded packagepackage57896-39257896-392-16DDiscontinued by firm2026-10-15

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 · 36 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 packagepackage57896-392-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57896-392-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57896-392-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57896-392-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57896-392-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57896-392-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57896-392-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57896-392-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57896-392-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57896-392-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57896-392-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57896-392-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57896-392-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57896-392-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57896-392-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57896-392-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57896-392-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57896-392-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57896-392-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57896-392-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57896-392-16367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57896-392-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57896-392-16557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57896-392-08557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-392-08ML - Milliliter57896-3920d1d551f-aa40-4bed-a505-1be757c816dc12018-02-20
57896-392-16ML - Milliliter57896-39209dadf6e-45f7-46d1-a7b5-f416c0545eb012018-11-06

DailyMed Socrata Ingredients#

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