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 29 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	RITE AID CORPORATION	9889cf9e-3f6a-4abc-b723-0b295c7c8f93	2024-10-30	Warnings	Exact identifier application number: M001
Rite Aid Pharmacy Extra Strength Assorted Berries	CALCIUM CARBONATE	RITE AID CORPORATION	f697de02-7df9-4419-9835-8b65bbaf4215	2024-10-29	Warnings	Exact identifier application number: M001
Premier Value Smooth Antacid Extra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	0de2c4c5-46fb-4081-aa96-b36794e3983f	2024-10-28	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Extra Strength Tropical Fruit	ANTACID TABLETS	Chain Drug Consortium	8999b9c1-05d0-496b-88f2-062908a4fadc	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Extra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	ef8ab31b-d050-446a-bca9-4a94d4ba1752	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Extra Strength Original Flavor	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	PHARMACY VALUE ALLIANCE, LLC	e33db45a-594e-4af8-ab16-10010fc8a388	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Extra Strength Freshmint Flavor	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE	CHAIN DRUG CONSORTIUM, LLC	1192ebeb-f6cc-45db-8f07-12d36eb55a5f	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Maximum Strength Assorted Fruit	CALCIUM CARBONATE, SIMETHICONE	PHARMACY VALUE ALLIANCE, LLC	e25bf9ca-415b-4a3e-a502-59074308da54	2024-10-25	Warnings	Exact identifier application number: M001
PV Extra Strength Antacid	CALCIUM CARBONATE	PHARMACY VALUE ALLIANCE, LLC	8c92de83-ed60-46c3-b289-4b45a1915e24	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Ultra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	26c742a7-5806-44e0-bef0-c70a9d77dd23	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium, LLC	00a58373-77ab-4a46-9862-d179e17c731a	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Multi Symptom Antacid Berry Flavor	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONE	Pharmacy Value Alliance LLC	69e0c4a8-04ae-461b-bf47-4180bccd91d6	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Regular Strength Chewable Antacid Peppermint Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium, LLC	245e195f-fd67-497b-83d4-fef75cea8b5b	2024-10-25	Warnings	Exact identifier application number: M001
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	53380470-5748-6fa7-548e-7484ef204c0f	2024-10-21	Warnings	Exact identifier application number: M001
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	8723fe90-8402-4511-b6c6-b71cf98513e3	2024-10-21	Warnings	Exact identifier application number: M001
Citrus Flavored Antacid	CALCIUM CARBONATE	JHK DBA American Safety & First Aid	79f2b495-a438-408e-9572-b6c3516db52c	2024-10-15	Warnings	Exact identifier application number: M001
NUTRALOX	CALCIUM CARBONATE	A-S Medication Solutions	524e26a9-c69f-4e25-b83d-f4c65adca83d	2024-10-11	Warnings	Exact identifier application number: M001
Mag-AL Liquid	ALUMINUM HYDROXIDE AND MAGNESIUM HYDROXIDE	PAI Holdings, LLC	b1f2d137-f5f7-4800-a1df-ef5d25544bc9	2024-10-08	Warnings	Exact identifier application number: M001
Melox	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Belmora LLC	bfc78d44-dc90-4f69-85af-a23dd70c68d2	2024-10-04	Warnings	Exact identifier application number: M001
HEB Extra Strength sugar free Antacid 174	CALCIUM CARBONATE	H E B	17cd3717-2fc3-1693-e063-6394a90ae03d	2024-09-17	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