Quality Choice
- Product NDC
- 83324-335
- Requested package NDC
- 83324-335-01
- 11-digit product format
- 833240335
- Labeler code
- 83324
- Product ID
- 83324-335_3d02651a-0fb7-6954-e063-6294a90aa9ef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- EMULSION
- Route
- ORAL
- Labeler
- QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-01
- Substance
- DIMETHICONE, UNSPECIFIED
- Active strength
- 20 mg/.3mL
- 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
- Quality Choice
- Brand name suffix
- Infants Gas Relief Dye Free
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE, UNSPECIFIED | 20 mg/.3mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198857 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83324-335-01 | Quality ChoiceInfants Gas Relief Dye Free | 30 mL in 1 BOTTLE, DROPPER | EMULSION | 30 | 1 | |
| 83324-335-01 | Quality ChoiceInfants Gas Relief Dye Free | 1 in 1 CARTON | EMULSION | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| GNP Regular Strength Gas Relief | DIMETHICONE | Amerisource Bergen | 7b63b265-e4f2-4103-935c-22d2d89cc5e8 | 2024-12-26 | Warnings | M002 |
| Infants Gas relief | SIMETHICONE | Topco Associates, LLC | fd6a2537-8db2-492d-b045-6404df2fb9c3 | 2024-12-26 | Warnings | M002 |
| Equaline Stomach Relief | BISMUTH SUBSALICYLATE | UNITED NATURAL FOODS, INC. DBA UNFI | 5dae8bbe-219b-4aa1-bf7f-6471fa2856d9 | 2024-12-20 | Warnings | M002 |
| GNP Stomach Relief | BISMUTH SUBSALICYLATE 525 MG | Amerisource Bergen | ead13b6b-de37-49f9-b18e-68096651d47e | 2024-12-20 | Warnings | M002 |
| Infants Gas relief | SIMETHICONE | UNITED NATURAL FOODS, INC. DBA UNFI | a9902ba0-f239-4e66-8d66-7cef39a5fdc3 | 2024-12-20 | Warnings | M002 |
| GNP Pink Bismuth | BISMUTH SUBSALICYLATE | Amerisource Bergen | a6ed50d5-574f-4d6b-be48-e14659338993 | 2024-12-20 | Warnings | M002 |
| WinCo Foods Gas Relief Extra Strength Softgels | SIMETHICONE | WinCo Foods, LLC | a1a19ef7-4a14-4fcb-8917-631d867be0bb | 2024-12-18 | Warnings | M002 |
| Discount Drugmart Gas Relief Extra Strength Softgels | SIMETHICONE | Discount Drug Mart, Inc | 63f3e5f0-10da-4681-a4f1-8ca1eb7e390f | 2024-12-18 | Warnings | M002 |
| Quality Choice Gas Relief Extra Strength Softgels | SIMETHICONE | Chain Drug Marketing Association | 06dfb541-fd1f-4cee-a4a6-44252f1f65a0 | 2024-12-18 | Warnings | M002 |
| Leader Gas relief | SIMETHICONE | CARDINAL HEALTH 110, LLC. DBA LEADER | 0163d372-222e-4a8d-a5cb-5a7af9a7068c | 2024-12-17 | Warnings | M002 |
| Maximum Strength Gas Relief Softgel-60ct | SIMETHICONE | HEB | f65e362a-2f90-428a-b885-eefdad8cae1e | 2024-12-16 | Warnings | M002 |
| Maximum Strength Gas Relief | SIMETHICONE | Chain Drug Marketing Association, Inc. | e8b2c528-121d-519a-e053-2a95a90a4119 | 2024-12-16 | Warnings | M002 |
| Gas Relief Ultra Strength | DIMETHICONE | TOPCO ASSOCIATES LLC | b9a4c876-722b-4d6c-807f-005ccf5df320 | 2024-12-14 | Warnings | M002 |
| Gas Relief Extra Strength | DIMETHICONE | TOPCO ASSOCIATES LLC | bb1c54d4-3a36-4b77-8659-2e92845d2f0e | 2024-12-14 | Warnings | M002 |
| Foster and Thrive Extra Strength Gas Relief Cherry | SIMETHICONE | Strategic Sourcing Services LLC | e47374c8-05c1-4874-871b-e83d9b305bd3 | 2024-12-13 | Warnings | M002 |
| Gas-X Extra Strength | SIMETHICONE | Haleon US Holdings LLC | 7ce312ca-542b-4bc0-97b5-f65279e1e84c | 2024-12-13 | Warnings | M002 |
| Antacid Antigas | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | Retail Business Services, LLC. | c8173d42-f900-4527-aa56-472d1177a9bc | 2024-12-11 | Warnings | M002 |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | 0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36 | 2024-11-25 | Warnings | M002 |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | f7c40b12-11e4-4b85-afb2-0ea33e4f218c | 2024-11-25 | Warnings | M002 |
| Simethicone | SIMETHICONE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | 346df37d-b0fc-4fa5-8c19-492fed58c239 | 2024-11-25 | Warnings | M002 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198857 | simethicone 20 MG in 0.3 mL Oral Suspension | PSN | 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 | 1 |
| 198857 | simethicone 66.7 MG/ML Oral Suspension | SCD | 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 | 1 |
| 198857 | simethicone 20 MG per 0.3 ML Oral Suspension | SY | 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 | 1 |
| 198857 | simethicone 40 MG per 0.6 ML Oral Suspension | SY | 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83324-335-01 | 83324033501 | 1 BOTTLE, DROPPER in 1 CARTON (83324-335-01) / 30 mL in 1 BOTTLE, DROPPER | 2025-08-01 | No | No | Current |