Direct Safety Ibuprofen
- Product NDC
- 61245-084
- 11-digit product format
- 612450084
- Labeler code
- 61245
- Product ID
- 61245-084_3e5d726a-c5b3-989b-e063-6394a90aeb7d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Conney Safety Products, LLC
- Application
- ANDA079174
- Marketing category
- ANDA
- Marketing start
- 2014-11-17
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Direct Safety Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61245-084-13 | Direct Safety Ibuprofen | 250 in 1 BOX | TABLET, COATED | 250 | | 9 |
| 61245-084-13 | Direct Safety Ibuprofen | 2 in 1 PACKET | TABLET, COATED | 2 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61245-084 | DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240117_07afce34-aaea-50a1-e054-00144ff88e88.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 |
|---|
| 61245-084-13 | 61245008413 | 250 PACKET in 1 BOX (61245-084-13) / 2 TABLET, COATED in 1 PACKET | 250 packet | 2014-11-17 | 0000-00-00 | No | No | Current |