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 |
|---|---|---|---|---|---|---|
| Cold and Allergy | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DOLGENCORP, LLC | b55452e1-25d0-4db5-9621-83f21ec6c298 | 2026-04-06 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Strategic Sourcing Services LLC | c9fa8d93-d9d6-4206-a13d-32b9e7555e7f | 2026-04-02 | Warnings | M012 |
| Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 6aaed3fe-ce35-4533-aea4-80096ce8e57a | 2026-04-02 | Warnings | M012 |
| Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 19879fc8-4962-4c6e-87ed-b874d1d564af | 2026-04-01 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Lidl US LLC | 7227b330-590b-4731-8a58-e05a0233dd8a | 2026-04-01 | Warnings | M012 |
| SudoGest | CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | 7cd8f7f3-c262-4f7c-bcaf-068be2c952f9 | 2026-04-01 | Warnings | M012 |
| Sanatos Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 4c26be18-733a-e4a8-e063-6294a90a8b02 | 2026-04-01 | Warnings | M012 |
| Sanatos Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 4c26c8bf-0143-ddca-e063-6294a90a3552 | 2026-04-01 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Method Pharmaceuticals, LLC | fe126254-6ee6-48c3-965c-96e4276a5314 | 2026-04-01 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief | GUAIFENESIN | AmerisourceBergen Drug Corp | 200dddd9-e3ff-4cec-a164-d1c9a698f121 | 2026-03-31 | Warnings | M012 |
| Head and Cold | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Hi-Tech Nutraceuticals, LLC | a39c772b-3cce-14cb-e053-2a95a90a733b | 2026-03-31 | Warnings | M012 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 44217a8c-7656-a0f6-e063-6294a90af2ad | 2026-03-31 | Warnings | M012 |
| Dr Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CalmCo LLC | 3f156679-7a91-aff1-e063-6394a90a18f6 | 2026-03-31 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | A-S Medication Solutions | c26da6e0-ab1c-46c2-acf5-0074958c03cd | 2026-03-31 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | ba174fcc-da1e-420c-bf9c-179ad65c2848 | 2026-03-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Amerisource Bergen | 8e0c6f8d-559c-45de-9362-1b713fd78a7a | 2026-03-30 | Warnings | M012 |
| Dr. Simi Daytime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG | Farmacias De Similares TX LLC | 4e448fd0-cb6b-b69b-e063-6394a90afde8 | 2026-03-30 | Warnings | M012 |
| Dr. Simi Nighttime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG | Farmacias De Similares TX LLC | 4e5772ee-586c-6191-e063-6294a90a132d | 2026-03-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HCL | HyVee Inc | 75b19163-db1c-42fc-8bbb-364be16b9b2f | 2026-03-30 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | a9f23c63-eeda-4de9-aec6-fe482f469e98 | 2026-03-27 | 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 |