FDA.reportPublic FDA data

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; DIMETHICONE; MAGNESIUM HYDROXIDE
Active strength
400; 40; 400 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

Additional Listing Data#

Finished product
Yes
Brand name base
ALMACONE DOUBLE STRENGTH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE400 mg/5mL
DIMETHICONE40 mg/5mL
MAGNESIUM HYDROXIDE400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QB0T2IUN0, 92RU3N3Y1O, NBZ3QY004S
Rxcui210000, 237870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-0015-83ALMACONE DOUBLE STRENGTH355 mL in 1 BOTTLESUSPENSION3556

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-0015-83ML - Milliliter0536-001567151b8a-7e0f-42e4-8011-8579b7877f4c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
HYDROXIDE IONACTIVE MOIETY9159UV381PALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-0015ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES]6Current NDC, Legacy NDC, 1 package rows20231103_25f22cff-2864-4853-a7f8-8edd9f8f3c29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210000Almacone Double Strength 400 MG / 400 MG / 40 MG in 5 mL Oral SuspensionPSN25f22cff-2864-4853-a7f8-8edd9f8f3c296
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN25f22cff-2864-4853-a7f8-8edd9f8f3c296
210000aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Almacone]SBD25f22cff-2864-4853-a7f8-8edd9f8f3c296
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD25f22cff-2864-4853-a7f8-8edd9f8f3c296
210000Almacone Double Strength 400 MG / 400 MG / 40 MG per 5 ML Oral SuspensionSY25f22cff-2864-4853-a7f8-8edd9f8f3c296
210000Almacone-2 (aluminum hydroxide 400 MG/ magnesium hydroxide 400 MG / simethicone 40 MG) per 5 ML Oral SuspensionSY25f22cff-2864-4853-a7f8-8edd9f8f3c296
210000Almacone-2 (aluminum hydroxide 80 MG / magnesium hydroxide 80 MG / simethicone 8 MG) per ML Oral SuspensionSY25f22cff-2864-4853-a7f8-8edd9f8f3c296
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY25f22cff-2864-4853-a7f8-8edd9f8f3c296
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY25f22cff-2864-4853-a7f8-8edd9f8f3c296
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY25f22cff-2864-4853-a7f8-8edd9f8f3c296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-0015-8300536001583355 mL in 1 BOTTLE (0536-0015-83) 355 ml2013-08-012022-08-01NoNoCurrent