Home NDC 49348-953-44 Sunmark Stomach relief
Product NDC 49348-953
Requested package NDC 49348-953-44
11-digit product format 493480953
Labeler code 49348
Product ID 49348-953_a8dc8bda-40d3-456c-853f-d972b920741e
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Strategic Sourcing Services LLC
Application part335
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-09-24
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISMUTH SUBSALICYLATE ACTIVE INGREDIENT 62TEY51RR1 SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1 BISMUTH SUBSALICYLATE ACTIVE MOIETY 62TEY51RR1 SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SUNMARK STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MCKESSON] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49348-953-44 49348095344 5 BLISTER PACK in 1 CARTON (49348-953-44) > 6 TABLET, CHEWABLE in 1 BLISTER PACK 5 blister pack 2019-09-24 0000-00-00 No No Current