ALMACONE DOUBLE STRENGTH

Product NDC: 0536-0015
11-digit product format: 005360015
Labeler code: 0536
Product ID: 0536-0015_09306334-8341-db28-e063-6394a90a376f
Type: HUMAN OTC DRUG
Nonproprietary name: aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form: SUSPENSION
Route: ORAL
Labeler: RUGBY LABORATORIES
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-01-05
Substance: ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength: 400; 400; 40 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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: ALMACONE DOUBLE STRENGTH
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALUMINUM HYDROXIDE	400 mg/5mL
MAGNESIUM HYDROXIDE	400 mg/5mL
DIMETHICONE	40 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QB0T2IUN0	Internal UNII lookup
NBZ3QY004S	Internal UNII lookup
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
210000	Internal RxNorm lookup
237870	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
25f22cff-2864-4853-a7f8-8edd9f8f3c29	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-0015-83	ALMACONE DOUBLE STRENGTH	355 mL in 1 BOTTLE	SUSPENSION	355		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-0015-83	ML - Milliliter	0536-0015	67151b8a-7e0f-42e4-8011-8579b7877f4c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-0015	ALMACONE DOUBLE STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [RUGBY LABORATORIES]	6	Current NDC, Legacy NDC, 1 package rows	20231103_25f22cff-2864-4853-a7f8-8edd9f8f3c29.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 9 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rolaids Ultra Strength Mint	CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Chattem, Inc.	8806c912-ab83-4f45-ac78-e826bb3143d4	2026-01-14	Warnings	Exact identifier application number: M001
Rolaids Advanced Antacid Anti-gas Wild Berry	CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONE	Chattem, Inc.	07649a83-0123-4bb5-b130-3067c7d052c5	2026-01-14	Warnings	Exact identifier application number: M001
CVS Health Extra Strength Sugar Free Antacid	ANTACID	CVS Pharmacy,Inc.	f722e7ce-6cca-4850-a230-7510c7ca7754	2026-01-12	Warnings	Exact identifier application number: M001
MGC Health Calcium Carbonate Antacid Assorted Fruits	CALCIUM CARBONATE	Medical Group Care LLC	47e1a46c-5665-ac4c-e063-6294a90a9b81	2026-01-08	Warnings	Exact identifier application number: M001
MGC Health Calcium Carbonate Antacid Assorted Fruits	CALCIUM CARBONATE	Medical Group Care LLC	47e19b30-3784-ad98-e063-6294a90aa566	2026-01-08	Warnings	Exact identifier application number: M001
MGC Health Calcium Carbonate Antacid Tropical Fruit	CALCIUM CARBONATE	Medical Group Care LLC	47e1bc32-baf5-ad9a-e063-6294a90ad5b4	2026-01-08	Warnings	Exact identifier application number: M001
MGC Health Calcium Carbonate Antacid Assorted Berries	CALCIUM CARBONATE	Medical Group Care LLC	47e1c7c7-4f3b-c04b-e063-6394a90a775f	2026-01-08	Warnings	Exact identifier application number: M001
Sanar Baking Soda 8oz 100% pure	SODIUM BICARBONATE	Evi Labs	47e7f801-3176-288c-e063-6394a90abef4	2026-01-08	Warnings	Exact identifier application number: M001
Xpect Antacid	CALCIUM CARBONATE	Cintas Corporation	3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c	2026-01-08	Warnings	Exact identifier application number: M001
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 Floz	SODIUM BICARBONATE	Evi Labs	47330d09-7db1-254d-e063-6294a90ae7de	2026-01-07	Warnings	Exact identifier application number: M001
DE LA CRUZ SODIUM BICARBONATE ANTACID	SODIUM BICARBONATE	DLC Laboratories, Inc.	fc469943-9749-45ee-93f7-90fdbcdc7215	2026-01-07	Warnings	Exact identifier application number: M001
De La Cruz Desempacho	SODIUM BICARBONATE	DLC LABORATORIES, INC.	741e105a-3ed2-4fc7-ab06-273e515a2d16	2026-01-07	Warnings	Exact identifier application number: M001
ANTACID AND ANTIGAS	CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE	Geri-Care Pharmaceuticals, Corp	472eafe8-aa7a-f435-e063-6294a90acf6b	2025-12-30	Warnings	Exact identifier application number: M001
ANTACID AND ANTIGAS	CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE	Geri-Care Pharmaceuticals, Corp	472f5bfc-c676-56da-e063-6294a90a74af	2025-12-30	Warnings	Exact identifier application number: M001
ANTACID AND ANTIGAS	CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE	Geri-Care Pharmaceuticals, Corp	472ffa66-938f-14e7-e063-6394a90ad0ca	2025-12-30	Warnings	Exact identifier application number: M001
QC Ultra Strength Antacid Soft Chews, Cherry	QC ANTACID SOFT CHEWS, CHERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26a97517-d3e7-d896-e063-6394a90acc95	2025-12-29	Warnings	Exact identifier application number: M001
Tums Chewy Bites	CALCIUM CARBONATE	Select Consumer Group	3caa037e-3424-f9ce-e063-6294a90ac1e8	2025-12-27	Warnings	Exact identifier application number: M001
Antacid	ANTACID	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	17adb983-bb28-bf8b-e063-6394a90a7daa	2025-12-26	Warnings	Exact identifier application number: M001
Sodium Bicarbonate 10 gr	SODIUM BICARBONATE	GRAXCELL PHARMACEUTICAL, LLC	897dbb09-fb47-4e03-8cae-bf76d48a7a03	2025-12-25	Warnings	Exact identifier application number: M001
Gas Relief	SIMETHICONE	H-E-B	3f9f6560-312f-44b7-e063-6394a90a1c56	2025-12-24	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
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
210000	Almacone Double Strength 400 MG / 400 MG / 40 MG in 5 mL Oral Suspension	PSN	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
237870	aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral Suspension	PSN	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
210000	aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Almacone]	SBD	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
237870	aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension	SCD	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
210000	Almacone Double Strength 400 MG / 400 MG / 40 MG per 5 ML Oral Suspension	SY	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
210000	Almacone-2 (aluminum hydroxide 400 MG/ magnesium hydroxide 400 MG / simethicone 40 MG) per 5 ML Oral Suspension	SY	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
210000	Almacone-2 (aluminum hydroxide 80 MG / magnesium hydroxide 80 MG / simethicone 8 MG) per ML Oral Suspension	SY	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
237870	aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral Suspension	SY	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
237870	aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral Suspension	SY	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6
237870	aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral Suspension	SY	25f22cff-2864-4853-a7f8-8edd9f8f3c29	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-0015-83	00536001583	355 mL in 1 BOTTLE (0536-0015-83)	355 ml	2013-08-01	2022-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RUG ALMACONE DS	RUGBY LABORATORIES \| GCP Laboratories	2023-11-02	HUMAN OTC DRUG LABEL	6
RUG ALMACONE DS	REMEDYREPACK INC.	2022-03-18	HUMAN OTC DRUG LABEL	6
RUG ALMACONE DS	NuCare Pharmaceuticals,Inc.	2021-12-20	HUMAN OTC DRUG LABEL	1