KAO-TIN PEPPERMINT FLAVOR

Product NDC
0904-5709
11-digit product format
009045709
Labeler code
0904
Product ID
0904-5709_7e067a40-441b-25d4-e053-2a91aa0a1fc6
Type
HUMAN OTC DRUG
Nonproprietary name
bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
MAJOR Pharmaceuticals Inc.
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-02-14
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 productproduct0904-5709DDiscontinued by firm2026-08-11
excluded packagepackage0904-57090904-5709-09DDiscontinued by firm2026-08-11
excluded packagepackage0904-57090904-5709-16DDiscontinued 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 · 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 packagepackage0904-5709-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-5709-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5709-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5709-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5709-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5709-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5709-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5709-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5709-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5709-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5709-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5709-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5709-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5709-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5709-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5709-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5709-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5709-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5709-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5709-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5709-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5709-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5709-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5709-16557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5709-09ML - Milliliter0904-57098e96136c-edaa-4338-8bb1-af3e93a1a14a12012-07-24
0904-5709-16ML - Milliliter0904-57093ce62bc0-75f7-4c54-aaf0-8f4eb32f161212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1KAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
BISMUTH SUBSALICYLATEACTIVE MOIETY62TEY51RR1KAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311KAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYPKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554KAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEKAO-TIN PEPPERMINT FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [MAJOR PHARMACEUTICALS INC.]1