FDA.reportPublic FDA data

Aluminum Hydroxide

Product NDC
0536-0091
11-digit product format
005360091
Labeler code
0536
Product ID
0536-0091_45aff4ec-4b96-2833-e063-6394a90a2f26
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-02-01
Substance
ALUMINUM HYDROXIDE
Active strength
320 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aluminum Hydroxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE320 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308078Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27c574a5-1fe0-4973-9a31-9beb4fc6ec46Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-0091-85Aluminum Hydroxide473 mL in 1 BOTTLELIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-0091-85ML - Milliliter0536-0091afd883fa-768d-4748-b1db-49ebdc5a3c1412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)INACTIVE INGREDIENTZYD53NBL45ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)INACTIVE INGREDIENTZYD53NBL45ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
SORBITOLINACTIVE INGREDIENT506T60A25RALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-0091ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 1 package rows20231103_27c574a5-1fe0-4973-9a31-9beb4fc6ec46.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
308078aluminum hydroxide 320 MG in 5 mL Oral SuspensionPSN60a54d4e-89c2-4329-86bf-a288527f37b57
308078aluminum hydroxide 64 MG/ML Oral SuspensionSCD60a54d4e-89c2-4329-86bf-a288527f37b57
308078aluminum hydroxide 320 MG per 5 ML Oral SuspensionSY60a54d4e-89c2-4329-86bf-a288527f37b57
308078aluminum hydroxide 320 MG in 5 mL Oral SuspensionPSN27c574a5-1fe0-4973-9a31-9beb4fc6ec464
308078aluminum hydroxide 64 MG/ML Oral SuspensionSCD27c574a5-1fe0-4973-9a31-9beb4fc6ec464
308078aluminum hydroxide 320 MG per 5 ML Oral SuspensionSY27c574a5-1fe0-4973-9a31-9beb4fc6ec464
308078aluminum hydroxide 320 MG in 5 mL Oral SuspensionPSNaf9b799f-69c5-401c-9c43-a97b23384cc21
308078aluminum hydroxide 64 MG/ML Oral SuspensionSCDaf9b799f-69c5-401c-9c43-a97b23384cc21
308078aluminum hydroxide 320 MG per 5 ML Oral SuspensionSYaf9b799f-69c5-401c-9c43-a97b23384cc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-0091-8500536009185473 mL in 1 BOTTLE (0536-0091-85) 473 ml2017-07-010000-00-00NoNoCurrent