ADVANCED REGULAR STRENGTH ANTACID

Product NDC: 0363-1639
11-digit product format: 003631639
Labeler code: 0363
Product ID: 0363-1639_4262805c-b01e-afb0-e063-6394a90a89ff
Type: HUMAN OTC DRUG
Nonproprietary name: aluminum hydroxide, magnesium hydroxide, simethicone
Dosage form: SUSPENSION
Route: ORAL
Labeler: WALGREEN COMPANY
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-01-01
Substance: ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength: 200; 200; 20 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: ADVANCED REGULAR STRENGTH ANTACID
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALUMINUM HYDROXIDE	200 mg/5mL
MAGNESIUM HYDROXIDE	200 mg/5mL
DIMETHICONE	20 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307746	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
5faf6229-b0fd-58df-e053-2a91aa0ab3bb	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
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
0363-1639-12	ADVANCED REGULAR STRENGTH ANTACID	355 mL in 1 BOTTLE	SUSPENSION	355		7
0363-1639-26	ADVANCED REGULAR STRENGTH ANTACID	769 mL in 1 BOTTLE	SUSPENSION	769		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-1639	ADVANCED REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [WALGREEN COMPANY]	6	Current NDC, Legacy NDC, 2 package rows	20241222_5faf6229-b0fd-58df-e053-2a91aa0ab3bb.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 · 667 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Goodsense Extra Strength Antacid	CALCIUM CARBONATE	GoodSense	193a1805-9f57-29cd-e063-6394a90ab99f	2024-09-13	Warnings	Exact identifier application number: M001
QCH Maximum Strength Antacid 516	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Chain Drug Marketing Association Inc.	1794c35a-79c5-48c2-e063-6394a90a6d29	2024-08-28	Warnings	Exact identifier application number: M001
QCH Regular Strength Antacid 509	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Chain Drug Marketing Association Inc.	17947ccd-6f11-d4cd-e063-6294a90a108a	2024-08-27	Warnings	Exact identifier application number: M001
Regular Strength Antacid Antigas	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Chain Drug Marketing Association Inc.	17dfe539-923b-e623-e063-6294a90a041f	2024-08-27	Warnings	Exact identifier application number: M001
QCH Extra Strength Gas Relief Cherry Flavor 134CHR	SIMETHICONE	Chain Drug Marketing Association Inc.	17e3300c-3d31-b7e1-e063-6294a90af082	2024-08-27	Warnings	Exact identifier application number: M001
Quality Choice Infants Non-staining Gas relief	SIMETHICONE	Chain Drug Marketing Association Inc.	17e181e5-6527-54d0-e063-6294a90addc2	2024-08-23	Warnings	Exact identifier application number: M001
Tums Chewy Bites	CALCIUM CARBONATE	Haleon US Holdings LLC	72ac000c-90f7-42e2-88a6-740de114a954	2024-08-21	Warnings	Exact identifier application number: M001
GDC Extra strength Alkums Antacid 127AF	CALCIUM CARBONATE	Guardian Drug Company	1b6da4a3-cfa6-6d98-e063-6394a90a5889	2024-08-13	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
307746	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension	PSN	5faf6229-b0fd-58df-e053-2a91aa0ab3bb	7
307746	aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension	SCD	5faf6229-b0fd-58df-e053-2a91aa0ab3bb	7
307746	aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension	SY	5faf6229-b0fd-58df-e053-2a91aa0ab3bb	7
307746	aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension	SY	5faf6229-b0fd-58df-e053-2a91aa0ab3bb	7
307746	aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension	SY	5faf6229-b0fd-58df-e053-2a91aa0ab3bb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-1639-12	00363163912	355 mL in 1 BOTTLE (0363-1639-12)	355 ml	2015-01-01	0000-00-00	No	No	Current
0363-1639-26	00363163926	769 mL in 1 BOTTLE (0363-1639-26)	769 ml	2015-01-01	0000-00-00	No	No	Current