Quality Choice Infants Non-staining Gas relief
- Product NDC
- 83324-133
- 11-digit product format
- 833240133
- Labeler code
- 83324
- Product ID
- 83324-133_90e2b49f-a358-4228-9b0c-130ebafd5640
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- SOLUTION/ DROPS
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association Inc.
- Application
- M001
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-21
- Substance
- DIMETHICONE
- 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 Infants Non-staining Gas relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 20 mg/.3mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 17e181e5-6527-54d0-e063-6294a90addc2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 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 |
|---|---|---|---|---|---|---|
| 83324-133-01 | Quality Choice Infants Non-staining Gas relief | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 2 | |
| 83324-133-01 | Quality Choice Infants Non-staining Gas relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83324-133-01 | ML - Milliliter | 83324-133 | 50d8f59d-d821-455f-aa82-ebb4765ad9c2 | 1 | 2025-08-11 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | VALU MERCHANDISERS COMPANY | 5e82a4f4-c7da-09cb-e053-2a91aa0abf5b | 2023-11-01 | Warnings | M001 |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | WAL-MART STORES, INC. | 7cc2ad32-fdff-0772-e053-2a91aa0aad9e | 2023-11-01 | Warnings | M001 |
| MAXIMUM STRENGTH ANTACID CHERRY | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE | WAL-MART STORES, INC. | 7cc2771e-abd7-4120-e053-2a91aa0a8af0 | 2023-11-01 | Warnings | M001 |
| MINTOX MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | Proficient Rx LP | b7711b50-c14a-44d6-b647-1f31284f87ea | 2023-11-01 | Warnings | M001 |
| MAXIMUM STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | VALU MERCHANDISERS COMPANY | 5e811783-cbf6-d0e3-e053-2991aa0ae69f | 2023-10-31 | Warnings | M001 |
| REGULAR STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | CVS | 5f880b43-2977-7a2d-e053-2991aa0a024d | 2023-10-31 | Warnings | M001 |
| MAXIMUM STRENGTH ANTACID | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | CVS PHARMACY | d5661964-9d2c-7a3d-e053-2995a90a86ef | 2023-10-31 | Warnings | M001 |
| EXTRA STRENGTH HEARTBURN RELIEF | ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE | CVS PHARMACY,INC. | 53fc327e-e345-26f2-e054-00144ff8d46c | 2023-10-31 | Warnings | M001 |
| MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRY | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | VALU MERCHANDISERS COMPANY | 5e94cb90-b616-dcfe-e053-2a91aa0ada72 | 2023-10-31 | Warnings | M001 |
| CALCIUM CARBONATE CHEWABLE ANTACID | CALCIUM CARBONATE | Geri-Care Pharmaceutical Corp | 27d9b505-08bd-4261-a59d-6ddc4031be32 | 2023-10-25 | Warnings | M001 |
| CALCIUM CARBONATE | CALCIUM CARBONATE | Blessings International | 99d7e467-a3db-b4f0-e053-2a95a90a900f | 2023-10-25 | Warnings | M001 |
| Sodium Bicarbonate | SODIUM BICARBONATE | APNAR PHARMA LP | e206c240-55c2-2d00-e053-2a95a90a1779 | 2023-10-21 | Boxed warning, Warnings | M001 |
| Magnesium Oxide | MAGNESIUM OXIDE | APNAR PHARMA LP | e4ef2224-07e4-e913-e053-2995a90a28ed | 2023-10-21 | Warnings | M001 |
| Magnesium Oxide | MAGNESIUM OXIDE | Endo USA | d5c123f8-1396-4d8c-96d3-e5ade96a6ef8 | 2020-11-10 | Warnings | M001 |
| Magnesium Oxide | MAGNESIUM OXIDE | Endo USA | d3c5b01b-f0d6-4503-ab18-b1a72386e2c6 | 2020-06-03 | Warnings | M001 |
| Magnesium Oxide 400mg | MAGNESIUM OXIDE 400MG | Allegiant Health | 2ea68874-8c20-4284-bd0a-f07768057b83 | 2019-01-28 | Warnings | M001 |
| Calcium Antacid | CALCIUM CARBONATE | Allegiant Health | 51dd53e8-22ff-4967-9124-f15c3986e4dd | 2017-11-17 | Warnings | M001 |
| Calcium Antacid | CALCIUM CARBONATE | Allegiant Health | 551d6135-2650-4c27-a20d-d56a9aba7b71 | 2017-11-08 | Warnings | M001 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83324-133-01 | 83324013301 | 1 BOTTLE, DROPPER in 1 CARTON (83324-133-01) / 30 mL in 1 BOTTLE, DROPPER | 2024-08-21 | No | No | Current |