Home NDC 0536-1945-83 RULOX REGULAR
Product NDC 0536-1945
Requested package NDC 0536-1945-83
11-digit product format 005361945
Labeler code 0536
Product ID 0536-1945_b47bb730-c5df-14c2-e053-2995a90a1027
Type HUMAN OTC DRUG
Nonproprietary name aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form SUSPENSION
Route ORAL
Labeler RUGBY LABORATORIES
Application part331
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-01-05
Marketing end 2021-03-01
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 200 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALUMINUM HYDROXIDE ACTIVE INGREDIENT 5QB0T2IUN0 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 MAGNESIUM HYDROXIDE ACTIVE INGREDIENT NBZ3QY004S RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 ALUMINUM HYDROXIDE ACTIVE MOIETY 5QB0T2IUN0 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 HYDROXIDE ION ACTIVE MOIETY 9159UV381P RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [TYA PHARMACEUTICALS] 2 ALUMINUM HYDROXIDE ACTIVE INGREDIENT 5QB0T2IUN0 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 MAGNESIUM HYDROXIDE ACTIVE INGREDIENT NBZ3QY004S RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 ALUMINUM HYDROXIDE ACTIVE MOIETY 5QB0T2IUN0 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 HYDROXIDE ION ACTIVE MOIETY 9159UV381P RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 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 0536-1945-83 00536194583 355 mL in 1 BOTTLE (0536-1945-83) 355 ml 2013-09-01 2021-03-01 No No Current