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
Ingredient	Strength
ALUMINUM HYDROXIDE	320 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QB0T2IUN0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
27c574a5-1fe0-4973-9a31-9beb4fc6ec46	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-0091-85	Aluminum Hydroxide	473 mL in 1 BOTTLE	LIQUID	473		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-0091-85	ML - Milliliter	0536-0091	afd883fa-768d-4748-b1db-49ebdc5a3c14	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	INACTIVE INGREDIENT	ZYD53NBL45	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)	INACTIVE INGREDIENT	ZYD53NBL45	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-0091	ALUMINUM HYDROXIDE LIQUID [RUGBY LABORATORIES]	3	Current NDC, Legacy NDC, 1 package rows	20231103_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 13 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Extra Strength Heartburn ReliefChews	CALCIUM CARBONATE	Bayer HealthCare LLC.	51759451-63a8-0fb4-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Heartburn	ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)	Bayer HealthCare LLC.	55158e50-0327-2043-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Cool Action Extra Strength ReliefChews Mint	CALCIUM CARBONATE	Bayer HealthCare LLC.	849bd52a-b730-3ba7-e053-2a91aa0a507c	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChews Strawberry and Orange	CALCIUM CARBONATE	Bayer HealthCare LLC.	84771ac5-ad0b-e0ec-e053-2a91aa0a1b36	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Heartburn ReliefChews Strawberry and Orange	CALCIUM CARBONATE	Bayer HealthCare LLC.	8745ae49-e6d6-43d6-9530-bcdf0b6c90e5	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Heartburn ReliefChews	CALCIUM CARBONATE	Bayer HealthCare LLC.	bdb43d3b-ddcd-4359-a174-a5556e7c5f57	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Ultra Strength Heartburn ReliefChews	CALCIUM CARBONATE	Bayer HealthCare LLC.	7857c357-38cb-2f61-e053-2991aa0a6602	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Extra Strength	ANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRIN	Bayer HealthCare LLC.	49b73bd5-6465-05eb-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M001
Alka-Seltzer Gold	ALKA-SELTZER GOLD	Bayer HealthCare LLC.	0824bedb-413b-2fa0-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M001
CVS Tropical Fruit	ANTACID	CVS	321fce7a-90be-45f2-b3a5-6b92d4f6ddb3	2025-12-04	Warnings	Exact identifier application number: M001
Quality Choice Chewable Antacid Assorted Fruit	ANTACID TABLETS	Chain Drug Marketing Association	c1171d19-5694-4e6c-9865-40c5f62c4f05	2025-12-03	Warnings	Exact identifier application number: M001
Quality Choice Antacid Assorted Fruit	CALCIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION	bfb80841-edda-482b-b401-e5f1cd52440e	2025-12-03	Warnings	Exact identifier application number: M001
Quality Choice Regular Strength Peppermint Flavor	CALCIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION	ea1abf51-7d10-4b1f-8eca-c5f94892bfe7	2025-12-03	Warnings	Exact identifier application number: M001
QC Regular Strength	ANTACID	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	1dd6df9a-241b-4a85-b31a-0741e916ae46	2025-12-03	Warnings	Exact identifier application number: M001
Quality Choice Assorted Berries Extra Strength	CALCIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION	c7f26b0a-f2c4-4ed2-9673-52f90d1a41c9	2025-12-03	Warnings	Exact identifier application number: M001
Quality Choice Extra Strength Assorted Fruit	CALCIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION	639b39b5-44e0-4bba-8887-ce62cfac6837	2025-12-03	Warnings	Exact identifier application number: M001
QC Antacid Calcium Assorted Berry	CALCIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION INC.	82f5e540-a1b2-48e2-9b1d-ff52c29f7835	2025-12-03	Warnings	Exact identifier application number: M001
Quality Choice Ultra Strength Assorted Fruit	CALCIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION	63318b46-d47d-474c-8fb5-5e0d53b7adb4	2025-12-03	Warnings	Exact identifier application number: M001
Extra Strength Antacid Original Flavor	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION INC.	8064b01a-e049-4d49-a5b6-e72dbeb5daac	2025-12-03	Warnings	Exact identifier application number: M001
calcium antacidextra strength extra strength	CALCIUM CARBONATE	Rugby Laboratories	d761954f-940e-4833-87b7-173a921aade1	2025-12-03	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QB0T2IUN0	ALUMINUM HYDROXIDE	21645-51-2	ALUMINUM HYDROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308078	aluminum hydroxide 320 MG in 5 mL Oral Suspension	PSN	60a54d4e-89c2-4329-86bf-a288527f37b5	7
308078	aluminum hydroxide 64 MG/ML Oral Suspension	SCD	60a54d4e-89c2-4329-86bf-a288527f37b5	7
308078	aluminum hydroxide 320 MG per 5 ML Oral Suspension	SY	60a54d4e-89c2-4329-86bf-a288527f37b5	7
308078	aluminum hydroxide 320 MG in 5 mL Oral Suspension	PSN	27c574a5-1fe0-4973-9a31-9beb4fc6ec46	4
308078	aluminum hydroxide 64 MG/ML Oral Suspension	SCD	27c574a5-1fe0-4973-9a31-9beb4fc6ec46	4
308078	aluminum hydroxide 320 MG per 5 ML Oral Suspension	SY	27c574a5-1fe0-4973-9a31-9beb4fc6ec46	4
308078	aluminum hydroxide 320 MG in 5 mL Oral Suspension	PSN	af9b799f-69c5-401c-9c43-a97b23384cc2	1
308078	aluminum hydroxide 64 MG/ML Oral Suspension	SCD	af9b799f-69c5-401c-9c43-a97b23384cc2	1
308078	aluminum hydroxide 320 MG per 5 ML Oral Suspension	SY	af9b799f-69c5-401c-9c43-a97b23384cc2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-0091-85	00536009185	473 mL in 1 BOTTLE (0536-0091-85)	473 ml	2017-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aluminum Hydroxide - ATLANTIC BIOLOGICALS CORP.	ATLANTIC BIOLOGICALS CORP.	2025-12-15	HUMAN OTC DRUG LABEL	7
Rugby aluminum hydroxide	Rugby Laboratories \| GCP Laboratories	2025-12-11	HUMAN OTC DRUG LABEL	4
Aluminum Hydroxide - LLC Federal Solutions \| Safecor Health, LLC	LLC Federal Solutions \| Safecor Health, LLC	2013-08-12	HUMAN OTC DRUG LABEL	1