Gaviscon
- Product NDC
- 0135-0098
- 11-digit product format
- 001350098
- Labeler code
- 0135
- Product ID
- 0135-0098_02f611d3-df31-4514-86ae-9e81004acdbf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- aluminum hydroxide and magnesium carbonate
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M001
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-06-13
- Substance
- ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
- Active strength
- 160; 105 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0135-0098-26 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0135-0098-26 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0135-0098-26 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0135-0098-26 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 0135-0098-26 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
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
- Gaviscon
- Brand name suffix
- Extra Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALUMINUM HYDROXIDE | 160 mg/1 |
| MAGNESIUM CARBONATE | 105 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0E53J927NA | Internal UNII lookup |
| 5QB0T2IUN0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7f367927-c366-465c-a059-e2cfb337d562 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-02-01 | Drug Facts |
| 2023-04-18 | Drug Facts |
| 2022-07-29 | Drug Facts |
| 2020-11-18 | Drug Facts |
| 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0098-26 | GavisconExtra Strength | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0098-26 | EA - Each | 0135-0098 | 98dfc34c-1e3e-43c6-89da-0be8440a0c62 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0098 | GAVISCON EXTRA STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) TABLET, CHEWABLE GAVISCON REGULAR STRENGTH (ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC] | 16 | Current NDC, Legacy NDC, 1 package rows | 20250516_7f367927-c366-465c-a059-e2cfb337d562.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Premier Value Milk of Magnesia | MAGNESIUM HYDROXIDE | Pharmacy Value Alliance, LLC | c3cdaa2b-db34-872d-e053-2995a90a3826 | 2023-12-20 | Warnings | M001 |
| Calcium Carbonate | CALCIUM CARBONATE | Humco Holding Group, Inc. | 8b207b49-d3fd-4108-b611-dca27c9dc78a | 2023-12-15 | Warnings | M001 |
| Humco Dewees Carminative | MAGNESIUM CARBONATE | Humco Holding Group, inc. | 163bceeb-ca74-413e-88b9-5c7bc9bbeb0d | 2023-12-15 | Warnings | M001 |
| Humco Milk of Magnesia | MAGNESIUM HYDROXIDE | Humco Holding Group, Inc. | b6c90fb4-2673-7e29-e053-2995a90ae9e1 | 2023-12-15 | Warnings | M001 |
| Medis Sodium Bicarbonate | SODIUM BICARBONATE | Humco Holding Group, Inc | 5da32469-58fc-14b1-e053-2a91aa0a74c4 | 2023-12-15 | Warnings | M001 |
| Mylanta One Antacid/Anti-Gas | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE | Infirst Healthcare Inc. | aa694e0d-7891-4870-8106-dd57f1e29fb4 | 2023-12-11 | Warnings | M001 |
| Mylanta One Antacid/Anti-Gas | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE | Infirst Healthcare Inc. | ed1b03f0-fabc-4c1c-8e6d-9f15c380300c | 2023-12-11 | Warnings | M001 |
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | Rugby Laboratories | e73b5871-4a87-4473-ab00-5e5395be017d | 2023-12-06 | Warnings | M001 |
| Inon Ace | MAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDE | Sato Pharmaceutical Co., Ltd. | a6e4475c-dfac-493c-b98a-21473e3b59d5 | 2023-12-06 | Warnings | M001 |
| INON | ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATE | Sato Pharmaceutical Co., Ltd. | e86d9c57-c877-49f1-a405-95a9a226ccf3 | 2023-12-04 | Warnings | M001 |
| Aluminum hydroxide and Magnesium carbonate | ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE | Simpex Pharma Pvt. Ltd | e799a555-bfd0-4298-a5dc-aeb671815d40 | 2023-11-29 | Warnings | M001 |
| Inon Ace | MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE | Sato Pharmaceutical Co., Ltd. | 0af4355f-e160-409d-8471-2de98dbc6f7c | 2023-11-10 | Warnings | M001 |
| MAXIMUM STRENGTH ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fd00ead8-026c-6610-e053-6394a90a0f11 | 2023-11-08 | Warnings | M001 |
| REGULAR STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fd67566a-1078-019d-e053-6394a90a415c | 2023-11-08 | Warnings | M001 |
| MAXIMUM STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fd7a0a90-6570-c722-e053-6394a90a03f4 | 2023-11-08 | Warnings | M001 |
| GERI-LANTA SUPREME CHERRY | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE | Geri-Care Pharmaceuticals, Corp | 7fbc654b-a0d4-408c-bb5a-eb50b7b54382 | 2023-11-08 | Warnings | M001 |
| ANTACID ANTIGAS NTA | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5d6916ec-e87f-6421-e053-2991aa0a3364 | 2023-11-07 | Warnings | M001 |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5d68366d-fee9-2acf-e053-2991aa0a7e4b | 2023-11-07 | Warnings | M001 |
| ANTACID ANTIGAS NTA | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5d7ed0c5-911c-299a-e053-2a91aa0aae56 | 2023-11-07 | Warnings | M001 |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | AMERISOURCEBERGEN DRUG CORPORATION | 5e1eed65-0d4c-2d02-e053-2991aa0a95c1 | 2023-11-07 | Warnings | M001 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308072 | aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable Tablet | PSN | 7f367927-c366-465c-a059-e2cfb337d562 | 17 |
| 212978 | Gaviscon Extra Strength 160 MG / 105 MG Chewable Tablet | PSN | 7f367927-c366-465c-a059-e2cfb337d562 | 17 |
| 212978 | aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable Tablet [Gaviscon] | SBD | 7f367927-c366-465c-a059-e2cfb337d562 | 17 |
| 308072 | aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable Tablet | SCD | 7f367927-c366-465c-a059-e2cfb337d562 | 17 |
| 212978 | Gaviscon Extra Strength (aluminum hydroxide 160 MG / magnesium carbonate 105 MG) Chewable Tablet | SY | 7f367927-c366-465c-a059-e2cfb337d562 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0135-0098-26 | 00135009826 | 100 TABLET, CHEWABLE in 1 BOTTLE (0135-0098-26) | 2011-06-13 | 0000-00-00 | No | No | Current |