SinuLief
- Product NDC
- 85510-101
- 11-digit product format
- 855100101
- Labeler code
- 85510
- Product ID
- 85510-101_4084b4ad-91cf-9487-e063-6394a90a3cbe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RoseWell Pharmaceuticals LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-18
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SinuLief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LORATADINE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7AJO3BO7QN | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 311372 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 32619143-a782-3497-e063-6394a90aaaec | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85510-101-01 | SinuLief | 10 in 1 BLISTER PACK | TABLET | 10 | 2 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Medi-First Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9654f5cd-74d7-44a2-9674-666d1e94ffa7 | 2025-09-08 | Warnings | M012 |
| Otis Clapp Mygrex | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | f196f2c5-a100-42b1-bd01-0327b223838e | 2025-09-08 | Warnings | M012 |
| Medique Diphen | DIPHENHYDRAMINE HYDROCHLORIDE | Unifirst First Aid Corporation | b61ee2e0-2543-447d-9fc4-23363d46ce04 | 2025-09-08 | Warnings | M012 |
| Green Guard Allergy 2 Relief | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 16fddca9-a66b-41e6-9423-eaf091d3971e | 2025-09-08 | Warnings | M012 |
| Medique Medi-Phenyl | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | d7d62ac1-1333-4366-884b-26537766ce38 | 2025-09-08 | Warnings | M012 |
| Unishield Sinus Decongestant | PHENYLEPHRINE HCL | Unishield | b8f68d9d-2d38-414a-e053-2a95a90a15ec | 2025-09-08 | Warnings | M012 |
| McKesson Sinus Pain and Pressure Relief | ACETAMINOPHEN, PHENYLEPHRINE HCL | McKesson Medical-Surgical | e0cbb213-4f4f-4045-e053-2a95a90a2a18 | 2025-09-08 | Warnings | M012 |
| Medique Medicidin D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 1f172d58-4050-424b-9743-130d8e618fe8 | 2025-09-08 | Warnings | M012 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Unifirst First Aid Corporation | e8059137-efba-398c-e053-2a95a90a21f2 | 2025-09-08 | Warnings | M012 |
| Medique Medi-Mucus | DEXTROMETHORPHAN HBR, GUAIFENESIN | Unifirst First Aid Corporation | f3bb862a-9cb8-f644-e053-2a95a90a5f4f | 2025-09-08 | Warnings | M012 |
| Physicians Care Cough and Sore Throat | MENTHOL | Acme United Corporation | 4e02223d-f34b-333e-e054-00144ff8d46c | 2025-09-08 | Warnings | M012 |
| Physicians Care Non-Drowsy Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Acme United | 186ec543-1f23-75d6-e063-6294a90a46b9 | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Sinus Non-Drowsy | PHENYLEPHRINE HCL | Acme United Corporation | a6daf3ef-f386-4de4-b38e-d0b90c9ae62b | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Allergy Multi-Symptom Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Acme United Corporation | fd101c27-6ba9-4cd3-baec-a354504c37a0 | 2025-09-08 | Warnings | M012 |
| Green Guard Honey Lemon Cough Drop | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 8a94f090-61d6-4909-e053-2995a90aee38 | 2025-09-08 | Warnings | M012 |
| Green Guard Cough Drop Relief | MENTHOL | Unifirst First Aid Corporation | 0fc4cb11-8ff9-4eff-9588-c73eef4e0137 | 2025-09-08 | Warnings | M012 |
| Multi-Symptom Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, , | Unifirst First Aid Corporation | e6ea6faf-baff-a130-e053-2a95a90a085a | 2025-09-08 | Warnings | M012 |
| MEDIQUE Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 0d6b4443-16a1-4851-bb03-d7407167551d | 2025-09-08 | Warnings | M012 |
| Medique Sugar Free Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 92d13e19-4e7b-4565-970e-504abf02579a | 2025-09-08 | Warnings | M012 |
| Medique at Home Diphen | DIPHENHYDRAMINE HCL | Unifirst First Aid Corporation | b56d1966-efd7-56eb-e053-2995a90a89b5 | 2025-09-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | 32619143-a782-3497-e063-6394a90aaaec | 2 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | 32619143-a782-3497-e063-6394a90aaaec | 2 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | 32619143-a782-3497-e063-6394a90aaaec | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85510-101-01 | 85510010101 | 10 TABLET in 1 BLISTER PACK (85510-101-01) | 10 tablet | 2025-04-18 | No | No | Current |