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 |
|---|---|---|---|---|---|---|
| NIGHTTIME CHERRY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 36924420-f514-4225-e063-6294a90a330c | 2026-03-03 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS HEALTH CORP | 4584d701-5a4e-e54e-e063-6394a90a38d6 | 2026-03-03 | Warnings | M012 |
| foster and thrive nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Sportpharm LLC | 7bdfd2ef-bb99-41f5-97ae-3a02c994bddd | 2026-03-03 | Warnings | M012 |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | d27b5976-8cc0-4d99-96f6-9069b786affd | 2026-03-03 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | A-S Medication Solutions | 7f703c9c-2256-4524-9d31-c51919399d26 | 2026-03-03 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | f49f1e9a-07ac-443e-9df8-3281d5f35e78 | 2026-03-03 | Warnings | M012 |
| berkley and jensen nasal | OXYMETAZOLINE HYDROCHLORIDE | BJWC | 77cbe75d-4ed9-4a8b-91dc-1cc28af25508 | 2026-03-02 | Warnings | M012 |
| childrens cold and cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Walgreen Company | 6c7c950d-ed48-4428-9e9e-73684cabc699 | 2026-02-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Kroger Co. | 116146db-719f-4c48-8a8a-1120ea62b0d5 | 2026-02-27 | Warnings, Adverse reactions | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 1f737b76-14b5-618a-e063-6294a90a19c2 | 2026-02-27 | Warnings | M012 |
| WALGREENS NIGHTTIME ALLERGY RELIEF | DOXYLAMINE SUCCINATE | WALGREENS CO. | a3c7df98-4611-4b61-9c03-5e687364bf74 | 2026-02-27 | Warnings | M012 |
| MEIJER Childrens Allergy Relief Chews | DIPHENHYDRAMINE HCL | MEIJER DISTRIBUTION INC | 3368e081-a3b2-4c03-8bd1-05cc6af0391d | 2026-02-27 | Warnings | M012 |
| CVS PHARMACY Nighttime MS Flu Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CVS PHARMACY | 23cafaa1-34fe-4cef-960b-5f664ea32cb4 | 2026-02-27 | Warnings | M012 |
| Tussin DM Cough and Chest | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 402969c9-945c-44b7-b018-b62f427ce571 | 2026-02-26 | Warnings | M012 |
| nasal original | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | d997f264-1b4a-4cca-a282-bd9645d55bfd | 2026-02-26 | Warnings | M012 |
| Multi-Symptom Cold and Fever Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 2a569e47-3f17-4fc7-83d6-a3dddfd4987e | 2026-02-25 | Warnings | M012 |
| Cough and Chest Congestion DN, Cough DM Daytime, Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 184059b7-9238-480e-be4a-ed105f13c19d | 2026-02-25 | Warnings | M012 |
| Kids Daytime Cough and Nighttime Cough combo pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Genexa Inc. | 4bad39f1-86d4-b8a1-e063-6394a90a7a95 | 2026-02-25 | Warnings | M012 |
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 67072a38-1ae7-4e59-bfed-71db0d93215d | 2026-02-25 | Warnings | M012 |
| leader tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | b3e3699b-b36c-453c-8f3b-0001388c8e82 | 2026-02-25 | 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 |