Home NDC 0904-1315 Bismatrol
Product NDC 0904-1315
11-digit product format 009041315
Labeler code 0904
Product ID 0904-1315_055c5066-0e1f-4724-af9a-c2ff0a035ea1
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Major Pharmaceuticals
Application part335
Marketing category OTC MONOGRAPH FINAL
Marketing start 2003-01-03
Marketing end 0000-00-00
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
Pharmacologic classes Bismuth [CS], Bismuth [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-1315-46 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-1315-46 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0904-1315-46 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0904-1315-46 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0904-1315-46 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0904-1315-46 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-1315-46 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-1315-46 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-1315-46 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0904-1315-46 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0904-1315-46 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0904-1315-46 557ba5c1ecfa…9c80585c8c6e…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISMUTH SUBSALICYLATE ACTIVE INGREDIENT 62TEY51RR1 BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 BISMUTH CATION ACTIVE MOIETY ZS9CD1I8YE BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS] 2 BISMUTH SUBSALICYLATE ACTIVE INGREDIENT 62TEY51RR1 BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 BISMUTH CATION ACTIVE MOIETY ZS9CD1I8YE BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BISMATROL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-1315-46 00904131546 5 BLISTER PACK in 1 CARTON (0904-1315-46) > 6 TABLET, CHEWABLE in 1 BLISTER PACK 5 blister pack 2003-01-03 0000-00-00 No No Current