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
MAGNESIUM HYDROXIDE400 mg/5mL
DIMETHICONE40 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup
NBZ3QY004SInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
210000Internal RxNorm lookup
237870Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25f22cff-2864-4853-a7f8-8edd9f8f3c29Available on FDA.report

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

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 1 of 37 · 739 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Sana Lemon Alivio Digestivo UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59cdf417-e5c0-6bb2-e063-6294a90a9c512026-08-24WarningsExact identifier
application number: M001
Dr Sana Alivio Digestivo Naranja UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59d07c2d-ef11-bd32-e063-6394a90af87d2026-08-24WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
application number: M001
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
application number: M001
CVS Health Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY8629529e-4363-4d37-9ae0-27193868df322026-08-19WarningsExact identifier
application number: M001
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Heartburn Relief Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.5c32d90b-68a0-4acf-94b6-d02037cea3762026-08-13WarningsExact identifier
application number: M001
Extra Strength SmoothANTACID TABLETSCVSc00204f7-c343-4451-9e0f-638ebb72f07c2026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY Extra Strength Cherry FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.cf7ae053-fa8d-4e6e-af4f-b846699aaf242026-08-13WarningsExact identifier
application number: M001
CVS Extra Strength SmoothCALCIUM CARBONATECVS PHARMACY70752251-02fe-4639-a4a8-afef32463c322026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted BerryANTACID TABLETSCVS PHARMACY,INC.19f0847e-1512-465c-b67f-d61ef4a16cfa2026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Berry AntacidCALCIUM CARBONATECVS7f0a4d88-4e3c-448e-90b1-ae03966b78062026-08-12WarningsExact identifier
application number: M001
Extra StrengthANTACID TABLETSCVS PHARMACYf3cd6627-cd82-4d39-9593-55f016c72eec2026-08-12WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar FreeANTACIDCVS PHARMACY, INC.49e23561-d392-415c-9e6f-2dbcf64c96362026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Fruit AntacidCALCIUM CARBONATECVS8ab371eb-9839-47f0-b576-d917f69ed16d2026-08-12WarningsExact identifier
application number: M001
CVS Ultra StrengthANTACID TABLETSCVS6108271a-4336-4f90-9765-9c3aea1094882026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted FruitANTACID TABLETSCVS PHARMACY,INC.60294e90-4b9c-4419-876c-3da037d76cfd2026-08-12WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.4cdf0cd0-f69f-4f86-a9ff-cda5cb002d652026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.ec3f0e47-52f3-4ffd-a3d3-71ef4bd11f082026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.639665ca-476e-4fbf-9378-a08cb28c15f62026-08-11WarningsExact identifier
application number: M001

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