Application 018685

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GAVISCON	ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE	TABLET, CHEWABLE;ORAL	80MG;20MG	Yes	No
002	GAVISCON	ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE	TABLET, CHEWABLE;ORAL	160MG;40MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018685-001	GAVISCON	ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	1983-12-09
N018685-002	GAVISCON	ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	1983-12-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018685-001	GAVISCON	80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018685-002	GAVISCON	160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018685-001	GAVISCON	80MG;20MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018685-002	GAVISCON	160MG;40MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018685-001	GAVISCON	80MG;20MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018685-002	GAVISCON	160MG;40MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018685-001	GAVISCON	80MG;20MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018685-002	GAVISCON	160MG;40MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018685-001	GAVISCON	80MG;20MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018685-002	GAVISCON	160MG;40MG	TABLET, CHEWABLE / ORAL	RLD	1983-12-09	`74a2ff9319b5…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GAVISCON	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	Haleon US Holdings LLC	2d74e5bc-1f10-4fb6-9258-cd906e360013	2026-02-13	Warnings	Name fallback brand name: GAVISCON

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0096	Gaviscon	aluminum hydroxide and magnesium trisilicate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0096	Gaviscon	aluminum hydroxide and magnesium trisilicate	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current