Home NDC 57465-100 Estomarol
Product NDC 57465-100
11-digit product format 574650100
Labeler code 57465
Product ID 57465-100_9a73c6d0-db6a-8a66-e053-2995a90a6db6
Type HUMAN OTC DRUG
Nonproprietary name ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE
Dosage form POWDER
Route ORAL
Labeler Laboratorios Imperiales, S.A. de C.V.
Application part331
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-05-11
Marketing end 0000-00-00
Substance ALUMINUM HYDROXIDE; BISMUTH SUBCARBONATE; CALCIUM CARBONATE; MAGNESIUM CARBONATE; SODIUM BICARBONATE
Active strength 0 g/3.5g; g/3.5g; g/3.5g; g/3.5g; g/3.5g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 38 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 2025-08-27 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 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 57465-100-00 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product U Excluded because listing certification expired 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57465-100-00 U Excluded because listing certification expired 8dfbde2a14a4…c9ff85d89658…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 57465-100-00 I Inactivated by FDA 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALUMINUM HYDROXIDE ACTIVE INGREDIENT 5QB0T2IUN0 ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 BISMUTH SUBCARBONATE ACTIVE INGREDIENT M41L2IN55T ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 CALCIUM CARBONATE ACTIVE INGREDIENT H0G9379FGK ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 MAGNESIUM CARBONATE ACTIVE INGREDIENT 0E53J927NA ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 ALUMINUM CATION ACTIVE MOIETY 3XHB1D032B ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 BISMUTH CATION ACTIVE MOIETY ZS9CD1I8YE ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 MAGNESIUM CATION ACTIVE MOIETY T6V3LHY838 ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57465-100 ESTOMAROL (ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE) POWDER [LABORATORIOS IMPERIALES, S.A. DE C.V.] 3 Legacy NDC 20191225_7a1bc8d6-ce04-4ee6-bfa8-7fe087155975.zip