Simethicone
- Product NDC
- 11673-549
- 11-digit product format
- 116730549
- Labeler code
- 11673
- Product ID
- 11673-549_56a7c19f-eb0b-c89d-e063-6294a90aca84
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Target Berry Blast Antacid HBG Chew
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Target
- Application
- M001
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-01
- Substance
- DIMETHICONE; CALCIUM CARBONATE
- Active strength
- 80; 750 mg/1; mg/1
- Pharmacologic classes
- Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Simethicone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 80 mg/1 |
| CALCIUM CARBONATE | 750 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
| H0G9379FGK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1492387 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5245af45-77c7-c95f-e063-6294a90a24f7 | 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 |
|---|---|---|---|---|---|---|
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 11673-549-60 | 11673054960 | 60 TABLET, CHEWABLE in 1 BOTTLE (11673-549-60) | 2026-07-01 | No | No | Current |