FDA.reportPublic FDA data

Aluminum Hydroxide

Product NDC
0536-0091
Requested package NDC
0536-0091-85
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 38 · 742 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLC348d3dfa-6a52-4583-96e3-83c4bf2df45b2026-07-27WarningsExact identifier
application number: M001
Extra Strength Assorted BerryCALCIUM CARBONATEBJWCbc56a82e-b875-4a4c-9b49-4bfbc69187242026-07-22WarningsExact identifier
application number: M001
Best Choice Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)BEST CHOICE (VALU MERCHANDISERS COMPANY)1547b549-efd0-46da-8f91-3d7e4d4a2f3a2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)529d7da6-5997-41f5-bfb8-33d2bbdce78e2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Tropical FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)09e25e8e-a861-45cb-a919-36c30d3b7f7b2026-07-17WarningsExact identifier
application number: M001
LEADER ULTRA STRENGTHANTACID CALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADER713c74bf-f586-4c63-82aa-5ed3a611d7a02026-07-17WarningsExact identifier
application number: M001
Best Choice Regular StrengthCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)a05bc8e7-ffc1-4abb-ade5-c3394a7e49bd2026-07-17WarningsExact identifier
application number: M001
Fast Acting Heartburn Relief Peppermint FlavorCALCIUM CARBONATERaritan Pharmaceuticals Inca7c5a5db-bdfe-4601-ae51-dedd81626b0d2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthCALCIUM CARBONATE ,MAGNESIUM HYDROXIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)1989551d-b977-4d5e-8b01-153cd9d638fc2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Assorted BerryCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)412a5be3-2f90-483c-8169-b733861f3aa12026-07-17WarningsExact identifier
application number: M001
Best Choice Assorted FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)cd9e2e11-25a8-4096-870a-9d0269e6c7a92026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthSMOOTH ANTACID TABLETSBEST CHOICE (VALU MERCHANDISERS COMPANY)c5141eb9-d851-453e-b51c-f436a647495a2026-07-17WarningsExact identifier
application number: M001
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
application number: M001
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpe62f6f6f-59a9-4df4-91ca-a76c4de93fe02026-07-15WarningsExact identifier
application number: M001
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
application number: M001
Amazon Basics Cherry Antacid SCCALCIUM CARBONATEAmazon4b1d6e4e-8b59-ec06-e063-6394a90aa60d2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4b1bd2d1-c909-f5db-e063-6394a90a84bc2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4d695a90-6502-3020-e063-6394a90ab0c32026-07-15WarningsExact identifier
application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
application number: M001
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact 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