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

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
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 30 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodsense Extra Strength AntacidCALCIUM CARBONATEGoodSense193a1805-9f57-29cd-e063-6394a90ab99f2024-09-13WarningsExact identifier
application number: M001
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
application number: M001
QCH Regular Strength Antacid 509ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17947ccd-6f11-d4cd-e063-6294a90a108a2024-08-27WarningsExact identifier
application number: M001
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17dfe539-923b-e623-e063-6294a90a041f2024-08-27WarningsExact identifier
application number: M001
QCH Extra Strength Gas Relief Cherry Flavor 134CHRSIMETHICONEChain Drug Marketing Association Inc.17e3300c-3d31-b7e1-e063-6294a90af0822024-08-27WarningsExact identifier
application number: M001
Quality Choice Infants Non-staining Gas reliefSIMETHICONEChain Drug Marketing Association Inc.17e181e5-6527-54d0-e063-6294a90addc22024-08-23WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC72ac000c-90f7-42e2-88a6-740de114a9542024-08-21WarningsExact identifier
application number: M001
GDC Extra strength Alkums Antacid 127AFCALCIUM CARBONATEGuardian Drug Company1b6da4a3-cfa6-6d98-e063-6394a90a58892024-08-13WarningsExact identifier
application number: M001
Wonderbelly Maximum Strength Antacid - Sweet MintCALCIUM CARBONATEGinger Health Company17ddf76b-237a-eeee-e063-6294a90ac2052024-07-29WarningsExact identifier
application number: M001
Good Neighbor Pharmacy Antacid Regular StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation2847e82e-203e-4976-8c4f-4a5caa75ce002024-07-09WarningsExact identifier
application number: M001
Kirkland Ultra Stregth Antacid 171ABCALCIUM CARBONATECOSTCO WHOLESALE COMPANY1bea92e8-1b94-77b0-e063-6394a90a82122024-07-08WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa951fa64-7775-470e-e053-2995a90aefc42024-06-10WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals,Inc.5b1f4c78-d42e-32c7-e053-2991aa0a19852024-06-04WarningsExact identifier
application number: M001
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
application number: M001
Stomach Circle KBISMUTH SUBSALICYLATELil' Drug Store Products, Inc05e14009-b35d-4711-b6f0-89b6d060b3872024-05-06WarningsExact identifier
application number: M001
Tums Chewy Bites PeppermintCALCIUM CARBONATEHaleon US Holdings LLC45a44b2b-1633-49c5-8c55-9e9af3545c922024-05-03WarningsExact identifier
application number: M001
MINT ANTACID 100CALCIUM CARBONATEJHK Inc dba American Safety & First Aid2496aed6-68ec-44c4-afc9-f7fa41b2147b2024-04-24WarningsExact identifier
application number: M001
Tums Chewy Bites Assorted BerriesCALCIUM CARBONATENavajo Manufacturing Company Inc.1625c724-7ead-cc70-e063-6294a90aa5582024-04-15WarningsExact identifier
application number: M001
Gas-X Maximum Strength SoftgelsSIMETHICONEHaleon US Holdings LLC45d1e373-0717-47df-9160-619c451666f42024-04-05WarningsExact identifier
application number: M001
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLC62fc0a91-c44f-4546-a472-c183a2d954862024-04-05WarningsExact 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