dual action

Product NDC: 56062-321
11-digit product format: 560620321
Labeler code: 56062
Product ID: 56062-321_880a4dd5-eaff-4c87-a4b6-2e862b816610
Type: HUMAN OTC DRUG
Nonproprietary name: famotidine, calcium carbonate and magnesium hydroxide
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Publix Super Markets Inc
Application: ANDA077355
Marketing category: ANDA
Marketing start: 2008-12-05
Marketing end: 2020-02-29
Substance: FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE
Active strength: 10 mg/1; mg/1; mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	56062-321		D	Discontinued by firm	2026-10-05
excluded package	package	56062-321	56062-321-63	D	Discontinued by firm	2026-10-05
excluded package	package	56062-321	56062-321-71	D	Discontinued by firm	2026-10-05

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 · 36 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	56062-321-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	56062-321-63	`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	56062-321-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	56062-321-63	`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	56062-321-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	56062-321-63	`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	56062-321-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	56062-321-63	`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	56062-321-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	56062-321-63	`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	56062-321-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	56062-321-63	`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	56062-321-71	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	56062-321-63	`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	56062-321-71	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	56062-321-63	`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	56062-321-71	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	56062-321-63	`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	56062-321-71	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	56062-321-63	`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	56062-321-71	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	56062-321-63	`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	56062-321-71	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	56062-321-63	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL			2008-02-06

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
56062-321-63	EA - Each	56062-321	4f676225-ccb1-4192-a8d2-ddd302206bb0	1	2012-07-24
56062-321-71	EA - Each	56062-321	06785b55-ca22-4531-8f90-1045fa33cf78	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
CARBONATE ION	ACTIVE MOIETY	7UJQ5OPE7D	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
MAGNESIUM HYDROXIDE	ACTIVE MOIETY	NBZ3QY004S	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [PUBLIX SUPER MARKETS INC]	1

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dual action complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Publix Super Markets Inc	913073fe-22ce-40a3-ad22-bf3027c21e99	2025-08-14	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
UP AND UP DUAL ACTION ACID REDUCER ANTACID	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Target Corporation	8e925e57-9036-4658-bf07-578e22675af8	2025-08-11	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Acid Reducer Plus Antacid	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	CVS Pharmacy	d6f0b82c-3890-4e85-8b8a-354fb8d0b640	2025-08-11	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Acid Reducer Plus Antacid	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	CVS Pharmacy	509435e4-14fd-4e09-bdc1-ad295b46806b	2025-08-11	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
leader acid reducer complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Cardinal Health 110, LLC. dba Leader	6a492dd2-61f1-4020-bebd-fcc8e5647207	2025-07-08	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Kroger Company	bf2fcb88-418f-4d5d-85ba-ec165a53ab04	2025-07-07	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Equate Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Wal-Mart Stores Inc	cb683c1c-db81-40a9-9ec5-f8dfa0dcf812	2025-07-07	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	H E B	ea712fc4-7f27-4556-b1b8-028f3f6ce57a	2025-07-07	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
DG Health acid reducer complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Dolgencorp, LLC	95c2c515-0f31-49d9-b799-7aaded81a37c	2025-07-07	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
topcare dual action complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Topco Associates LLC	8ef70327-9a04-413b-b331-f5d3a94d6b36	2025-07-01	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Walgreen Company	3a456dab-0a2d-4e48-a8e2-e49a7acef963	2025-07-01	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	H E B	c1aa7efa-4be1-4c8f-8994-661dd60e1aa9	2025-07-01	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
leader acid reducer complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Cardinal Health 110, LLC. dba Leader	a5420ef1-313f-4561-baf1-7ae017ea343a	2025-07-01	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Signature Care Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Safeway	249b19fd-d5b3-4c93-92bb-f277797015b4	2025-03-27	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
foster and thrive acid reducer antacid	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Strategic Sourcing Services LLC	d23222e8-9f87-4892-bc35-203e945f935c	2023-10-31	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
injoy heartburn relief	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	L. Perrigo Company	aca1b9e5-a35e-4eef-b55a-4189cd1b2a02	2022-09-07	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
signature care acid reducer complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Safeway	885f43ab-5c14-417b-aab7-e887dfc48f2e	2022-07-20	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Kroger Company	522a256b-a7c0-4783-bfff-3dc6b5a2b315	2022-07-12	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Equate Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Wal-Mart Stores Inc	3400c3aa-15f2-4279-9623-72933298b3dd	2022-07-12	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Basic Care Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Amazon.com Services LLC	27235c87-2fe9-458f-8eb0-b9880199cd5a	2022-07-11	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Publix Super Markets, Inc. Dual Action Drug Facts	Publix Super Markets Inc	2019-12-19	HUMAN OTC DRUG LABEL	4