Gelusil

Product NDC: 65197-300
11-digit product format: 651970300
Labeler code: 65197
Product ID: 65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101
Type: HUMAN OTC DRUG
Nonproprietary name: Alumina, Magnesia, Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: WellSpring Pharmaceutical Corporation
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-09-24
Substance: ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; SILICON DIOXIDE
Active strength: 200; 200; 24; 1 mg/1; mg/1; mg/1; mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65197-300		D	Discontinued by firm		2026-10-15
excluded package	package	65197-300	65197-300-20	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65197-300-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65197-300-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65197-300-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65197-300-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65197-300-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65197-300-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65197-300-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65197-300-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65197-300-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65197-300-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65197-300-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65197-300-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Gelusil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALUMINUM HYDROXIDE	200 mg/1
MAGNESIUM HYDROXIDE	200 mg/1
DIMETHICONE, UNSPECIFIED	24 mg/1
SILICON DIOXIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QB0T2IUN0	Internal UNII lookup
NBZ3QY004S	Internal UNII lookup
92RU3N3Y1O	Internal UNII lookup
ETJ7Z6XBU4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
211633	Internal RxNorm lookup
307747	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
92fbeec1-1562-40f3-9734-41f133d494f9	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	SPL version
65197-300-10	Gelusil	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	26
65197-300-10	Gelusil	10 in 1 CARTON	TABLET, CHEWABLE	10	26
65197-300-11	Gelusil	100 in 1 BOTTLE	TABLET, CHEWABLE	100	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65197-300-10	EA - Each	65197-300	8e370643-937c-4fe1-95c4-c2ce1d50c130	1	2012-07-24
65197-300-11	EA - Each	65197-300	bdc6445f-2da5-4c62-8ddd-a4e3be901ec9	1	2020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
SILICON DIOXIDE	ACTIVE INGREDIENT	ETJ7Z6XBU4	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
SILICON DIOXIDE	ACTIVE MOIETY	ETJ7Z6XBU4	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
RAW SUGAR	INACTIVE INGREDIENT	8M707QY5GH	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10
SORBITOL	INACTIVE INGREDIENT	506T60A25R	GELUSIL (ALUMINUM HYDROXIDE DRIED GEL AND MAGNESIUM HYDROXIDE AND SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65197-300	GELUSIL (ALUMINA, MAGNESIA, SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	25	Current NDC, Legacy NDC, 3 package rows	20250110_92fbeec1-1562-40f3-9734-41f133d494f9.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 15 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPREME ANTACID	CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	FAMILY DOLLAR SERVICES INC	5e996df3-25a4-b259-e053-2a91aa0a4311	2025-11-19	Warnings	Exact identifier application number: M001
GERI-LANTA ANTACID ANTIGAS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	a7d7298f-44d6-4e09-8578-7fe311243002	2025-11-19	Warnings	Exact identifier application number: M001
GERI-MOX MAX CHERRY	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	8e57bcf5-2960-4c41-8bf2-83cb1ee50168	2025-11-19	Warnings	Exact identifier application number: M001
Tums Antacid Chewy Bites	CALCIUM CARBONATE 750 MG	R J General Corporation	6208d11d-0670-4a20-a3fc-ebc764a8e6cd	2025-11-17	Warnings	Exact identifier application number: M001
REGULAR STRENGTH ANTACID/ANTIGAS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	RUGBY LABORATORIES	b244fce9-9626-e947-e053-2995a90ab8f9	2025-11-17	Warnings	Exact identifier application number: M001
Antacid Childrens	CALCIUM CARBONATE	CVS Pharmacy	08953df1-cc29-452f-bc69-b19970a1fd2e	2025-11-15	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Marlex Pharmaceuticals Inc	0bb322a5-fb92-14de-e063-6294a90a4c1b	2025-11-14	Warnings	Exact identifier application number: M001
magnesium oxide	MAGNESIUM OXIDE	Marlex Pharmaceuticals Inc.	dc57893c-068a-37d8-e053-2a95a90aa054	2025-11-14	Warnings	Exact identifier application number: M001
Earthmed Soothe Chewable Orange	CITRIC ACID	Earthmed LLC	439543fe-ceb9-4c5c-e063-6294a90a9b70	2025-11-14	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID MINT	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	CVS	3ce054f3-2953-5f7d-e054-00144ff8d46c	2025-11-11	Warnings	Exact identifier application number: M001
Topcare Antacid Extra Strength Assorted Berry	CALCIUM CARBONATE	Topco Associates LLC	14f6f475-32d6-4783-8dcc-1fe265902d55	2025-11-10	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC	38c26f49-fb5e-480c-9164-bf5edcf0726b	2025-11-10	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC.	bb99b942-1f84-43e1-a18d-3a975cddc59e	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium Regular Strength	CALCIUM CARBONATE	Topco Associates LLC	2606ac08-9760-4ff6-8d90-51fbb04e6ac8	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium Extra Strength	CALCIUM CARBONATE	Topco Associates LLC	495d97b0-d95c-46d1-a76a-56ac7f823538	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium Extra Strength	CALCIUM CARBONATE	Topco Associates LLC.	73b4cda2-900a-4380-a0ae-0abfecdb7263	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Extra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	Topco Associates LLC	2677ca2b-b211-475e-a9c4-643fd54a744f	2025-11-08	Warnings	Exact identifier application number: M001
TopCare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC	b94eac38-62d0-49a2-bb49-053fda8129e2	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC	04b3d397-df99-44e2-a191-6e9199b08398	2025-11-08	Warnings	Exact identifier application number: M001
topcare Antacid Calcium Ultra Strength	CALCIUM CARBONATE	Topco Associates LLC	6e2788b3-1e33-4908-aa2c-475d69b94ee6	2025-11-08	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
ETJ7Z6XBU4	SILICON DIOXIDE	7631-86-9	SILICON DIOXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307747	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet	PSN	92fbeec1-1562-40f3-9734-41f133d494f9	26
211633	Gelusil Antacid & Anti-Gas 200 MG / 200 MG / 25 MG Chewable Tablet	PSN	92fbeec1-1562-40f3-9734-41f133d494f9	26
211633	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet [Gelusil]	SBD	92fbeec1-1562-40f3-9734-41f133d494f9	26
307747	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet	SCD	92fbeec1-1562-40f3-9734-41f133d494f9	26
307747	aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG Chewable Tab	SY	92fbeec1-1562-40f3-9734-41f133d494f9	26
211633	Gelusil (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG) Chewable Tablet	SY	92fbeec1-1562-40f3-9734-41f133d494f9	26
211633	Gelusil Antacid & Anti-Gas (aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG) Chewable Tablet	SY	92fbeec1-1562-40f3-9734-41f133d494f9	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65197-300-10	65197030010	10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	10 blister pack	2008-09-24	0000-00-00	No	No	Current
65197-300-11	65197030011	100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)		2018-12-01	0000-00-00	No	No	Current