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 |
|---|---|---|---|---|---|---|
| Leader Ultra Strength Antacid | CALCIUM CARBONATE | CARDINAL HEALTH 110, LLC. DBA LEADER | eab5a905-67fb-494e-8f55-aeeab4c2dce2 | 2025-08-22 | Warnings | M001 |
| Leader Extra Strength Antacid | CALCIUM CARBONATE | CARDINAL HEALTH 110, LLC. DBA LEADER | 81911f6d-7edf-4183-9720-2f20a5db498d | 2025-08-21 | Warnings | M001 |
| Gas Relief | SIMETHICONE | BJWC (Berkley & Jensen / BJ's) | 2f32dde8-502e-eefa-e063-6294a90abf20 | 2025-08-19 | Warnings | M001 |
| CVS Health Ultra Strength Natural Antacid Peppermint Flavor | ANTACID TABLETS | CVS Pharmacy,Inc. | 4f18fd8d-4d6a-4b1d-8a94-b64592f73ad0 | 2025-08-13 | Warnings | M001 |
| MGC Health Calcium Carbonate Antacid Assorted Berries | CALCIUM CARBONATE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | b84d80c6-0240-4276-8e47-74a918f3d86a | 2025-08-12 | Warnings | M001 |
| Antacid | CALCIUM CARBONATE | ProStat First Aid | 3bb49eb3-2eaa-af8d-e063-6294a90a4035 | 2025-08-06 | Warnings | M001 |
| Maximum Strength Antacid and Antigas | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Meijer, Inc. | 30a0455d-63e0-95cc-e063-6394a90ada6b | 2025-07-30 | Warnings | M001 |
| Sodium Bicarbonate Antacid | SODIUM BICARBONATE | Menper Distributors Inc. | 6efb4da0-03ae-4df6-acd7-e8023d20d4b3 | 2025-07-22 | Warnings | M001 |
| Gas-X Total Relief Maximum Strength | CALCIUM CARBONATE, SIMETHICONE | Haleon US Holdings LLC | edb0f11a-bdb7-484d-9257-09ff47b0fca4 | 2025-07-15 | Warnings | M001 |
| REGULAR STRENGTH ANTACID ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | WALGREEN COMPANY | 7cd9234e-d1cc-4cce-e053-2991aa0a457e | 2025-07-09 | Warnings | M001 |
| Sodium Bicarbonate | SODIUM BICARBONATE | Westminster Pharmaceuticals, LLC | 9dcfc778-5fd6-4c68-8d37-a5385e374617 | 2025-07-08 | Warnings | M001 |
| MGC Health Antacid Soft Chews Cherry Flavor | CALCIUM CARBONATE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3958ec0a-8f32-6918-e063-6294a90ac1c4 | 2025-07-07 | Warnings | M001 |
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Major Pharmaceuticals | 1bc90fa7-fcce-4a9b-862f-f30ab602ecab | 2025-07-07 | Warnings | M001 |
| KOSHER MEDS antacid | CALCIUM CARBONATE | Mollec Inc | 7783d6a2-56e3-4542-ad1d-60680e03532b | 2025-07-01 | Warnings | M001 |
| Nauzene Chewables Ginger Honey | SODIUM CITRATE | Kobayashi Healthcare International, Inc. | 25c9825d-a4e8-4671-e063-6294a90ab46d | 2025-06-24 | Warnings | M001 |
| Gaviscon Extra Strength | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | Haleon US Holdings LLC | 7f367927-c366-465c-a059-e2cfb337d562 | 2025-06-11 | Warnings | M001 |
| Calmicid AC Acid Reducer | FAMOTIDINE | Melaleuca, Inc. | 369ae213-cd23-57ba-e063-6394a90a87a6 | 2025-06-02 | Warnings | M001 |
| Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | American Health Packaging | 2faf291e-1d62-412a-a05e-e992cb7def6a | 2025-05-30 | Warnings | M001 |
| Kids Tummy Relief | CALCIUM CARBONATE | Genexa Inc. | a7831b84-1f51-9258-e053-2a95a90a901e | 2025-05-23 | Warnings | M001 |
| Calcium Carbonate | CALCIUM CARBONATE | Atlantic Biologicals Corps | 38654d22-2f8a-49d2-a1cd-06d341f11323 | 2025-05-12 | 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 |