SinuLief
- Product NDC
- 85510-101
- Requested package NDC
- 85510-101-01
- 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 |
|---|---|---|---|---|---|---|
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | efcf2edd-21a3-45f9-e053-2995a90a3865 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff65505-8846-35c2-e053-2a95a90a6b79 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | eff0fdfe-695a-4e62-e053-2a95a90ab50f | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff1a70f-fa71-52b2-e053-2995a90a038c | 2024-10-07 | Warnings | M012 |
| Honey Lemon Menthol Cough Drops | HONEY LEMON MENTHOL | Topco Associates LLC | f5be283b-524d-26af-e053-2995a90a3972 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff16ba3-7e30-aa93-e053-2995a90a64cb | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | ebf6bcf5-9384-052a-e053-2a95a90a30a5 | 2024-10-07 | Warnings | M012 |
| Rompe Pecho SF Flu SF Flu | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06eac696-e8f6-ac50-e063-6394a90a2ed6 | 2024-10-07 | Warnings | M012 |
| dg health nasal four | PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ceeeb016-8e46-40b8-9923-8a4270475f45 | 2024-10-04 | Warnings | M012 |
| Topcare Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 99bc8829-167b-4cf8-8421-57da369f24cd | 2024-10-04 | Warnings | M012 |
| basic care nasal | PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 858648f6-f454-4008-9ea8-ad060c217833 | 2024-10-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Navajo Manufacturing Company Inc. | f6068011-ad56-59b4-e053-2995a90ac016 | 2024-10-03 | Warnings | M012 |
| Benadryl Ultratabs | DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 76433e3c-142c-4704-8b2b-d602f008c377 | 2024-10-02 | Warnings | M012 |
| Afrin | OXYMETAZOLINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 65bf1556-f234-9439-e053-2a91aa0a3194 | 2024-10-02 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Proficient Rx LP | 4eab4344-d95e-4b19-a21e-9c8ad033863a | 2024-10-01 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Proficient Rx LP | a910320b-0585-40bd-928c-0406346281d0 | 2024-10-01 | Warnings | M012 |
| CareOne Nasal and Sinus Decongestant | PSEUDOEPHEDRINE HCL | American Sales Company | 81b31070-9b03-4ce4-8aac-a334544842ae | 2024-10-01 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Proficient Rx LP | 20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d | 2024-10-01 | Warnings | M012 |
| meijer Nighttime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 1bec5167-5fc5-2405-e063-6294a90a5358 | 2024-09-30 | Warnings | M012 |
| good sense tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | A-S Medication Solutions | 19b3db33-86d1-48f3-9525-c7c87a4b6899 | 2024-09-29 | 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 |