premier value infants gas relief
- Product NDC
- 68016-670
- 11-digit product format
- 680160670
- Labeler code
- 68016
- Product ID
- 68016-670_2b8605c2-dcb3-48e0-ac8e-9c583d0a758d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- EMULSION
- Route
- ORAL
- Labeler
- Chain Drug Consortium
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-01-09
- Substance
- DIMETHICONE, UNSPECIFIED
- Active strength
- 20 mg/.3mL
- Pharmacologic classes
- 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
- premier value infants gas relief
- 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 |
|---|---|
| 7b887e53-a70a-4f33-9472-e1175b24400a | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-670-00 | premier value infants gas relief | 1 in 1 CARTON | EMULSION | 1 | 8 | |
| 68016-670-00 | premier value infants gas relief | 30 mL in 1 BOTTLE, DROPPER | EMULSION | 30 | 8 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| 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 68016-670 |
| 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 |
|---|---|---|---|---|
| 198857 | simethicone 20 MG in 0.3 mL Oral Suspension | PSN | 7b887e53-a70a-4f33-9472-e1175b24400a | 8 |
| 198857 | simethicone 66.7 MG/ML Oral Suspension | SCD | 7b887e53-a70a-4f33-9472-e1175b24400a | 8 |
| 198857 | simethicone 20 MG per 0.3 ML Oral Suspension | SY | 7b887e53-a70a-4f33-9472-e1175b24400a | 8 |
| 198857 | simethicone 40 MG per 0.6 ML Oral Suspension | SY | 7b887e53-a70a-4f33-9472-e1175b24400a | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68016-670-00 | 68016067000 | 1 BOTTLE, DROPPER in 1 CARTON (68016-670-00) / 30 mL in 1 BOTTLE, DROPPER | 2015-01-09 | 0000-00-00 | No | No | Current |