TopCare health EXTRA STRENGTH Gas Relief SOFTGEL
- Product NDC
- 76162-538
- 11-digit product format
- 761620538
- Labeler code
- 76162
- Product ID
- 76162-538_3e0ea0d4-f46d-47be-b087-7e4538b22915
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-01
- Substance
- DIMETHICONE, UNSPECIFIED
- Active strength
- 125 mg/1
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- TopCare health EXTRA STRENGTH Gas Relief SOFTGEL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE, UNSPECIFIED | 125 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198852 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2ea0eb22-f679-d136-e063-6294a90a1dfe | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-538-05 | TopCare health EXTRA STRENGTH Gas Relief SOFTGEL | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 2 | |
| 76162-538-05 | TopCare health EXTRA STRENGTH Gas Relief SOFTGEL | 25 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 25 | 2 |
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 |
|---|---|---|---|---|---|---|
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | 346df37d-b0fc-4fa5-8c19-492fed58c239 | 2024-11-25 | Warnings | M002 |
| Extra Strength Gas Relief Cherry | SIMETHICONE | Retail Business Services, LLC. | 1e8ed36d-5236-163b-e063-6294a90ad6ec | 2024-11-22 | Warnings | M002 |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 0f9639fa-e1d0-460d-bc46-714a01cd9811 | 2024-11-21 | Warnings | M002 |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 852cec3b-6564-46b2-afe5-ecef31424237 | 2024-11-21 | Warnings | M002 |
| Ultra Strength Gas Relief | SIMETHICONE | Walgreen Co. | d33e413d-4add-459f-ba46-c23b49cfcc87 | 2024-11-21 | Warnings | M002 |
| Gas Relief | SIMETHICONE | Walgreen Co. | d87a20d4-dd1d-4897-9321-f81df2cfbcc7 | 2024-11-21 | Warnings | M002 |
| Ultra Strength Gas Relief | SIMETHICONE | Walgreen Co. | b14b647f-d729-47df-879d-ca08a30b995e | 2024-11-21 | Warnings | M002 |
| Ultra Strength Gas Relief | SIMETHICONE | Wal-Mart Stores Inc | 206d57ec-c854-496e-af53-7d8b2a208d85 | 2024-11-21 | Warnings | M002 |
| Simethicone | SIMETHICONE | WALGREEN CO. | 4d523979-e3ae-47e8-9092-00fdffc8bb0b | 2024-11-21 | Warnings | M002 |
| Gas Relief | SIMETHICONE | Wal-Mart Stores Inc | 69351cf9-3092-45ca-8b84-83e3737fa8d4 | 2024-11-21 | Warnings | M002 |
| Simethicone | SIMETHICONE | WALMART INC. | 79a9e0a3-9199-4397-ab29-b8a9c843cdf8 | 2024-11-21 | Warnings | M002 |
| Maximum Strength Gas Relief | SIMETHICONE | FOODHOLD U.S.A., LLC | c37def6e-bb10-41ba-8bce-b06c09edbe9f | 2024-11-21 | Warnings | M002 |
| Gas Relief Ultra Strength | SIMETHICONE 180 MG | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 2cfb8132-6de4-457d-880b-c870a38862ad | 2024-11-20 | Warnings | M002 |
| Gas-Aid | SIMETHICONE | Leosons Overseas Corp | d271bfcb-bf13-4a97-bc03-f1824826f15a | 2024-11-19 | Warnings | M002 |
| Gas-Aid Drops for infants | SIMETHICONE | Leosons Overseas Corp | 06665701-5f1c-4f8f-8775-e0a4a9ef2029 | 2024-11-19 | Warnings | M002 |
| Mag-AL Plus XS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE | PAI Holdings, LLC dba PAI Pharma | db0c47ab-5296-4195-9fa6-2e338b665094 | 2024-11-12 | Warnings | M002 |
| basic care gas relief | SIMETHICONE | Amazon.com Services LLC | ab1681df-aded-4b0c-9124-87196606183b | 2024-11-02 | Warnings | M002 |
| Good Sense Gas Relief Extra Strength | SIMETHICONE | L. Perrigo Company | 6b2d8591-cc58-457e-92b6-c719eee85605 | 2024-11-02 | Warnings | M002 |
| premier value infants gas relief | SIMETHICONE | Chain Drug Consortium | 7b887e53-a70a-4f33-9472-e1175b24400a | 2024-10-28 | Warnings | M002 |
| Premier Value Extra Strength | SIMETHICONE | PHARMACY VALUE ALLIANCE, LLC | df2b1b62-5bd2-4d02-86c2-537b965a8d20 | 2024-10-28 | Warnings | M002 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198852 | simethicone 125 MG Oral Capsule | PSN | 2ea0eb22-f679-d136-e063-6294a90a1dfe | 2 |
| 198852 | simethicone 125 MG Oral Capsule | SCD | 2ea0eb22-f679-d136-e063-6294a90a1dfe | 2 |
| 198852 | dimethicone 125 MG Oral Capsule | SY | 2ea0eb22-f679-d136-e063-6294a90a1dfe | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76162-538-05 | 76162053805 | 2 BLISTER PACK in 1 CARTON (76162-538-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2025-08-01 | No | No | Current |