Dye Free Childrens Acetaminophen
- Product NDC
- 0121-0966
- 11-digit product format
- 001210966
- Labeler code
- 0121
- Product ID
- 0121-0966_89d3db5b-5a3b-41d3-b2d1-223932ba25d1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-03-09
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dye Free Childrens Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 307668 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0966-00 | Dye Free Childrens Acetaminophen | 10 in 1 CASE | SUSPENSION | 10 | | 8 |
| 0121-0966-00 | Dye Free Childrens Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | | 8 |
| 0121-0966-05 | Dye Free Childrens Acetaminophen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 8 |
| 0121-0966-94 | Dye Free Childrens Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | | 8 |
| 0121-0966-94 | Dye Free Childrens Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0966 | DYE FREE CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 8 | Current NDC, Legacy NDC, 5 package rows | 20250207_a69fca9d-c0a0-4321-bf03-5c8e99cc07cc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-0966-00 | 00121096600 | 10 TRAY in 1 CASE (0121-0966-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05) | 10 tray | 2022-03-09 | 0000-00-00 | No | No | Current |
| 0121-0966-05 | 00121096605 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 0121-0966-94 | 00121096694 | 3 TRAY in 1 CASE (0121-0966-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05) | 3 tray | 2022-03-09 | 0000-00-00 | No | No | Current |