Flanax Pain Reliever/Fever Reducer
- Product NDC
- 67751-125
- 11-digit product format
- 677510125
- Labeler code
- 67751
- Product ID
- 67751-125_f706ab57-bb88-8e63-e053-6394a90a99c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Navajo Manufacturing Company Inc.
- Application
- ANDA090545
- Marketing category
- ANDA
- Marketing start
- 2020-07-20
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 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
- Flanax Pain Reliever/Fever Reducer
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67751-125-01 | Flanax Pain Reliever/Fever Reducer | 1 in 1 CARTON | TABLET | 1 | | 1 |
| 67751-125-01 | Flanax Pain Reliever/Fever Reducer | 2 in 1 PACKET | TABLET | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67751-125 | FLANAX PAIN RELIEVER/FEVER REDUCER (NAPROXEN SODIUM) TABLET [NAVAJO MANUFACTURING COMPANY INC.] | 1 | Current NDC, 2 package rows | 20230317_f706b406-58f2-9b82-e053-6394a90ab598.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67751-125-01 | 67751012501 | 1 PACKET in 1 CARTON (67751-125-01) / 2 TABLET in 1 PACKET | 1 packet | 2020-07-20 | No | No | Current |