Safrel Mucus Relief
- Product NDC
- 71309-460
- 11-digit product format
- 713090460
- Labeler code
- 71309
- Product ID
- 71309-460_df498e8e-dc9b-41e1-e053-2a95a90a42c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Safrel Pharmaceuticals, LLC.
- Application
- ANDA213420
- Marketing category
- ANDA
- Marketing start
- 2022-02-21
- Marketing end
- 0000-00-00
- Substance
- GUAIFENESIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71309-460-05 | Safrel Mucus Relief | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 1 |
| 71309-460-10 | Safrel Mucus Relief | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71309-460 | SAFREL MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [SAFREL PHARMACEUTICALS, LLC.] | 1 | Legacy NDC, 2 package rows | 20220519_df498e82-e1c8-51eb-e053-2a95a90a49b6.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 |
|---|
| 71309-460-05 | 71309046005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-460-05) | 2022-02-21 | 0000-00-00 | No | No | Current |
| 71309-460-10 | 71309046010 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-460-10) | 2022-02-21 | 0000-00-00 | No | No | Current |