Home NDC 0536-0015 ALMACONE DOUBLE STRENGTH
Product NDC 0536-0015
11-digit product format 005360015
Labeler code 0536
Product ID 0536-0015_09306334-8341-db28-e063-6394a90a376f
Type HUMAN OTC DRUG
Nonproprietary name aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form SUSPENSION
Route ORAL
Labeler RUGBY LABORATORIES
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-01-05
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 400; 400; 40 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ALMACONE DOUBLE STRENGTH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 400 mg/5mL MAGNESIUM HYDROXIDE 400 mg/5mL DIMETHICONE 40 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QB0T2IUN0 Internal UNII lookup NBZ3QY004S Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 210000 Internal RxNorm lookup 237870 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-0015-83 ALMACONE DOUBLE STRENGTH 355 mL in 1 BOTTLE SUSPENSION 355 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALUMINUM HYDROXIDE ACTIVE INGREDIENT 5QB0T2IUN0 ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 MAGNESIUM HYDROXIDE ACTIVE INGREDIENT NBZ3QY004S ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 ALUMINUM HYDROXIDE ACTIVE MOIETY 5QB0T2IUN0 ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 HYDROXIDE ION ACTIVE MOIETY 9159UV381P ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-0015 ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES] 6 Current NDC, Legacy NDC, 1 package rows 20231103_25f22cff-2864-4853-a7f8-8edd9f8f3c29.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 34 · 678 matching rows.
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 0536-0015-83 00536001583 355 mL in 1 BOTTLE (0536-0015-83) 355 ml 2013-08-01 2022-08-01 No No Current