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 |
|---|---|---|---|---|---|---|
| Mucinex Sinus Max Clear and Cool | ACETAMINOPHEN AND GUAIFENESIN | RB Health (US) LLC | 37de813a-54b7-672a-e063-6294a90a374e | 2025-06-18 | Warnings | M012 |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a1aeb41-a8fa-4116-8068-e11acd608e58 | 2025-06-18 | Warnings | M012 |
| NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c768f5-dabd-22d0-e063-6394a90af9e5 | 2025-06-17 | Warnings | M012 |
| DISCOUNT DRUG MART Childrens Allergy Chewable | DIPHENHYDRAMINE HCL | DISCOUNT DRUG MART | 51de95da-e8e8-48f0-9fa4-6191aa4a247b | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | 5f4af8e8-8550-45c7-a199-694efac9e7be | 2025-06-16 | Warnings | M012 |
| Halls Honey Lemon | MENTHOL | Mondelez Global LLC | 25eaae85-d516-40da-a472-70736ea2b75d | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | bad89968-22a7-4287-a57c-9e6206e574fe | 2025-06-16 | Warnings | M012 |
| Herbal Throat Drops | LEMON MINT HERBAL | Meijer, Inc. | 37dd58ad-95d1-568c-e063-6394a90a9433 | 2025-06-16 | Warnings | M012 |
| topcare childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | 40a6a7e3-6ec9-4005-9406-9d5b044b3c21 | 2025-06-16 | Warnings | M012 |
| Daytime Nighttime Sinus Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Target Corporation | 23f50b88-52c3-2029-e063-6394a90ac73e | 2025-06-14 | Warnings | M012 |
| Cough Drops Dollar General Berries Flavor 25ct | PECTIN | Dollar General Corporation | c53c19a9-5984-4b08-ae46-a53dc8bb7d74 | 2025-06-13 | Warnings | M012 |
| Cough Drops Dollar General Strawberry Flavor 25ct | PECTIN | Dollar General Corporation | d82034ca-b7fd-48c8-ab4a-8e1e56418324 | 2025-06-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Belleview Biosciences | 1db57d86-39f0-f8ca-e063-6394a90a6397 | 2025-06-12 | Warnings | M012 |
| TARGET Cold and Cough and Nighttime Value Pack | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL, | TARGET CORPORATION | ce536313-7265-405c-88b7-f45e62781da5 | 2025-06-11 | Warnings | M012 |
| Capron Max | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | 3756812b-f128-8946-e063-6294a90a59ba | 2025-06-11 | Warnings | M012 |
| SAFETUSSIN Non Drowsy Cough plus chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 60311ca3-8544-417e-aa29-e9f65c6692ba | 2025-06-11 | Warnings | M012 |
| Cold Max Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | e65d2815-6932-123c-e053-2a95a90a2cf9 | 2025-06-10 | Warnings | M012 |
| Cold Head Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | American Sales Company | 0cc66c6c-db26-4bb2-a97d-c4106210d70c | 2025-06-10 | Warnings | M012 |
| Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 75a9c736-bc7e-4b7f-84ea-9474a37508ec | 2025-06-10 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | 8877bb8d-479f-4968-8033-5c269d449a46 | 2025-06-10 | 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 |