Gaviscon
- Product NDC
- 0135-0430
- 11-digit product format
- 001350430
- Labeler code
- 0135
- Product ID
- 0135-0430_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 | 0135-0430-03 | 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 | 0135-0430-03 | 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 | 0135-0430-03 | 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 | 0135-0430-03 | 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 | 0135-0430-03 | 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 |
|---|---|---|---|---|---|---|
| 0135-0430-03 | 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 |
|---|---|---|---|---|---|
| 0135-0430-03 | EA - Each | 0135-0430 | 909107f4-1ed7-4afe-a965-cdc166c28a1c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0430 | 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 |
|---|---|---|---|---|---|---|
| Tums Chewy Bites | CALCIUM CARBONATE | Navajo Manufacturing Company Inc. | 297d6703-ed4e-10d3-e063-6394a90a9f3a | 2024-12-17 | Warnings | M001 |
| Calcium Carbonate 10 gr (648 mg) (Antacid) | CALCIUM CARBONATE 10GR (648 MG) | RUGBY LABORATORIES | f21c8cf7-45cb-492b-bf4a-462024a54569 | 2024-12-17 | Warnings | M001 |
| Extra Strength Antacid Tablets, Caseys 4good | CALCIUM CARBONATE 750 MG | Lil' Drug Store Prodsucts, Inc. | 026aefd6-bb80-1ffd-e063-6394a90a1262 | 2024-12-16 | Warnings | M001 |
| Foster and Thrive Regular Strength Antacid | CALCIUM CARBONATE | Strategic Sourcing Services LLC | 1aeb60fb-eebe-4e54-be1c-4e01f3b7269c | 2024-12-13 | Warnings | M001 |
| Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted Fruit | CALCIUM CARBONATE | Strategic Sourcing Services LLC | 8b2fabf7-4dc6-445a-842c-b28ae081fdc8 | 2024-12-13 | Warnings | M001 |
| Foster and Thrive Regular Strength Antacid Peppermint | CALCIUM CARBONATE | Strategic Sourcing Services LLC | 49d1b6c4-432b-44d3-b073-0185dbed7a90 | 2024-12-12 | Warnings | M001 |
| Mylanta Maximum Strength Classic Flavor | ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 56853b20-a2aa-4b19-a428-3dde232114c6 | 2024-12-11 | Warnings | M001 |
| Mylanta New Tonight Soothing Honey Chamomile | CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 123f3005-a0a0-4970-94f1-f6d04741078b | 2024-12-11 | Warnings | M001 |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | NuCare Pharmaceuticals, Inc. | fd160cfd-9ad4-81c7-e053-6394a90a33f6 | 2024-12-11 | Warnings | M001 |
| Topcare Ultra Strength Antacid Peppermint | CALCIUM CARBONATE | Topco Associates, LLC | fb434059-7b6e-42e0-acfa-db9879f6a4e4 | 2024-12-11 | Warnings | M001 |
| TopCare Ultra Strength Antacid Assorted Fruit | CALCIUM CARBONATE | Topco Associates, LLC | dd038b15-2ecb-4ee2-b356-db6d87c2f01b | 2024-12-11 | Warnings | M001 |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | 74823298-d24a-4ffe-8446-1661305372b2 | 2024-12-11 | Warnings | M001 |
| Extra Strength Antacid Smooth Dissolve Assorted Fruit | CALCIUM CARBONATE | UNITED NATURAL FOODS, INC. DBA UNFI | 1b6a48a7-0703-2d3d-e063-6394a90a4641 | 2024-12-11 | Warnings | M001 |
| Careone Regular Strength Calcium Antacid | CALCIUM CARBONATE | Retail Business Services, LLC. | bdd9a64d-777b-45e0-8a9a-6cdc54baf898 | 2024-12-11 | Warnings | M001 |
| Careone Regular Strength calcium Antacid | CALCIUM CARBONATE | Retail Business Services, LLC. | cb6e12cc-4b88-4046-a9fc-2dbe4bca965e | 2024-12-11 | Warnings | M001 |
| TopCare Ultra Strength Antacid Assorted Berry | CALCIUM CARBONATE | Topco Associates, LLC | c10c56ba-51cf-47f9-80a8-aa188859608f | 2024-12-11 | Warnings | M001 |
| Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | ce2edc57-e550-4aa9-bbfe-37933913c9eb | 2024-12-11 | Warnings | M001 |
| GERI-LANTA MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Geri-Care Pharmaceuticals, Corp | b8712a98-30b7-4154-a5bf-0095ef901412 | 2024-12-09 | Warnings | M001 |
| HEARTBURN RELIEF | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | GERI-CARE PHARMACEUTICALS, CORP | 1f1dbf41-cb87-37d4-e063-6394a90ae294 | 2024-12-09 | Warnings | M001 |
| MAXIMUM STRENGTH Antacid | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Geri-Care Pharmaceuticals, Corp | 25c93d2a-3c48-ca3a-e063-6294a90a312e | 2024-12-09 | 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 |
|---|---|---|---|---|---|---|---|
| 0135-0430-03 | 00135043003 | 100 TABLET, CHEWABLE in 1 BOTTLE (0135-0430-03) | 2011-06-13 | 0000-00-00 | No | No | Current |