Infants
- Product NDC
- 0536-1303
- 11-digit product format
- 005361303
- Labeler code
- 0536
- Product ID
- 0536-1303_41f5317f-a058-f03c-e063-6394a90a321a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- SUSPENSION/ DROPS
- Route
- ORAL
- Labeler
- RUGBY LABORATORIES
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-09-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Infants
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE, UNSPECIFIED | 20 mg/.3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O |
| Rxcui | 198857 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1303-75 | Infants | 30 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 30 | | 6 |
| 0536-1303-75 | Infants | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1303 | INFANTS (SIMETHICONE) SUSPENSION/ DROPS [RUGBY LABORATORIES] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241102_c6fa71bc-de48-47f4-80c4-7d92643d2664.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0536-1303-75 | 00536130375 | 1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75) / 30 mL in 1 BOTTLE, DROPPER | 2020-09-01 | 0000-00-00 | No | No | Current |