Home NDC 0076-0903 Ustell
Product NDC 0076-0903
11-digit product format 000760903
Labeler code 0076
Product ID 0076-0903_45c7c55c-ce7d-1f92-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Dosage form CAPSULE
Route ORAL
Labeler Star Pharmaceuticals LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2010-09-27
Marketing end 0000-00-00
Substance METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
Active strength 120 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0076-0903-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0076-0903-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0076-0903-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0076-0903-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0076-0903-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0076-0903-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0076-0903-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0076-0903-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0076-0903-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0076-0903-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0076-0903-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0076-0903-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0076-0903-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0076-0903-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0076-0903-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0076-0903-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0076-0903-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0076-0903-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0076-0903-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0076-0903-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0076-0903-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0076-0903-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0076-0903-01 Ustell 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hyoscyamine Sulfate ACTIVE INGREDIENT F2R8V82B84 USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Methenamine ACTIVE INGREDIENT J50OIX95QV USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Methylene Blue ACTIVE INGREDIENT T42P99266K USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Phenyl Salicylate ACTIVE INGREDIENT 28A37T47QO USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Sodium Phosphate, Monobasic, Monohydrate ACTIVE INGREDIENT 593YOG76RN USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Hyoscyamine ACTIVE MOIETY PX44XO846X USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Methenamine ACTIVE MOIETY J50OIX95QV USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Methylene Blue ACTIVE MOIETY T42P99266K USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Phenyl Salicylate ACTIVE MOIETY 28A37T47QO USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Sodium Cation ACTIVE MOIETY LYR4M0NH37 USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Ammonia INACTIVE INGREDIENT 5138Q19F1X USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Anhydrous Dibasic Calcium Phosphate INACTIVE INGREDIENT L11K75P92J USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Shellac INACTIVE INGREDIENT 46N107B71O USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0076-0903 USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC] 2 Legacy NDC, 1 package rows 20170111_dc773b57-378b-4650-9bb0-34e6f8c067ab.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 0076-0903-01 00076090301 100 in 1 BOTTLE Historical