COMPLETE ACID REDUCER
- Product NDC
- 51316-407
- 11-digit product format
- 513160407
- Labeler code
- 51316
- Product ID
- 51316-407_6769e338-14cc-4ad2-adbe-abcbbc297589
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- famotidine, calcium carbonate and magnesium hydroxide
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- ANDA077355
- Marketing category
- ANDA
- Marketing start
- 2026-07-13
- Substance
- FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
- Active strength
- 10; 800; 165 mg/1; mg/1; mg/1
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COMPLETE ACID REDUCER
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FAMOTIDINE | 10 mg/1 |
| CALCIUM CARBONATE | 800 mg/1 |
| MAGNESIUM HYDROXIDE | 165 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5QZO15J2Z8 | Internal UNII lookup |
| H0G9379FGK | Internal UNII lookup |
| NBZ3QY004S | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 283641 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 962ced24-0fb3-4aba-b32e-2e6fa1c1c5d7 | Available on FDA.report |
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.
| 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 | 077355 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 | 077355 ANDA077355 |
| Acid Reducer Plus Antacid | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | CVS Pharmacy | d6f0b82c-3890-4e85-8b8a-354fb8d0b640 | 2025-08-11 | Warnings | 077355 ANDA077355 |
| Acid Reducer Plus Antacid | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | CVS Pharmacy | 509435e4-14fd-4e09-bdc1-ad295b46806b | 2025-08-11 | Warnings | 077355 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 | 077355 ANDA077355 |
| Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Kroger Company | bf2fcb88-418f-4d5d-85ba-ec165a53ab04 | 2025-07-07 | Warnings | 077355 ANDA077355 |
| Equate Acid Reducer Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Wal-Mart Stores Inc | cb683c1c-db81-40a9-9ec5-f8dfa0dcf812 | 2025-07-07 | Warnings | 077355 ANDA077355 |
| Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | H E B | ea712fc4-7f27-4556-b1b8-028f3f6ce57a | 2025-07-07 | Warnings | 077355 ANDA077355 |
| DG Health acid reducer complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Dolgencorp, LLC | 95c2c515-0f31-49d9-b799-7aaded81a37c | 2025-07-07 | Warnings | 077355 ANDA077355 |
| topcare dual action complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Topco Associates LLC | 8ef70327-9a04-413b-b331-f5d3a94d6b36 | 2025-07-01 | Warnings | 077355 ANDA077355 |
| Acid Reducer Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Walgreen Company | 3a456dab-0a2d-4e48-a8e2-e49a7acef963 | 2025-07-01 | Warnings | 077355 ANDA077355 |
| Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | H E B | c1aa7efa-4be1-4c8f-8994-661dd60e1aa9 | 2025-07-01 | Warnings | 077355 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 | 077355 ANDA077355 |
| Signature Care Acid Reducer Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Safeway | 249b19fd-d5b3-4c93-92bb-f277797015b4 | 2025-03-27 | Warnings | 077355 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 | 077355 ANDA077355 |
| injoy heartburn relief | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | L. Perrigo Company | aca1b9e5-a35e-4eef-b55a-4189cd1b2a02 | 2022-09-07 | Warnings | 077355 ANDA077355 |
| signature care acid reducer complete | FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Safeway | 885f43ab-5c14-417b-aab7-e887dfc48f2e | 2022-07-20 | Warnings | 077355 ANDA077355 |
| Dual Action Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Kroger Company | 522a256b-a7c0-4783-bfff-3dc6b5a2b315 | 2022-07-12 | Warnings | 077355 ANDA077355 |
| Equate Acid Reducer Complete | FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE | Wal-Mart Stores Inc | 3400c3aa-15f2-4279-9623-72933298b3dd | 2022-07-12 | Warnings | 077355 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 | 077355 ANDA077355 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 51316-407-63 | 51316040763 | 25 TABLET, CHEWABLE in 1 BOTTLE (51316-407-63) | 2026-07-13 | No | No | Current |