NDC 55553-478 - ACL10SPSL12 SINGLE SHOT EPIDURAL
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 55553-478
- Package NDCs from labels
- 55553-478-02
- Manufacturer
- Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.
- Effective date
- 2012-09-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| IODINE - Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc. | Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc. | 2012-09-07 | MEDICAL DEVICE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52380-0001-3 | ACL10SPSL12 SINGLE SHOT EPIDURAL | 22.5 mL in 1 PACKET | SOLUTION | 22.5 mL | 0.10 mg in 1mL | 1 |
| 55553-478-02 | ACL10SPSL12 SINGLE SHOT EPIDURAL | 30 in 1 CASE | KIT | 30 | 1 | |
| 55553-478-02 | ACL10SPSL12 SINGLE SHOT EPIDURAL | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.] | 1 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.] | 1 | |
| NONOXYNOL-9 | INACTIVE INGREDIENT | 48Q180SH9T | ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ACL10SPSL12 SINGLE SHOT EPIDURAL () KIT [CLINT PHARMACEUTICALS, INC.] | 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.