Cough Drops
- Product NDC
- 83455-201
- 11-digit product format
- 834550201
- Labeler code
- 83455
- Product ID
- 83455-201_23f96ca4-4913-cab8-e063-6394a90a9ec6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- PASTILLE
- Route
- ORAL
- Labeler
- United Natural Foods, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-12
- Substance
- MENTHOL
- Active strength
- 5.8 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
- Cough Drops
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 5.8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 476973 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f9f0d020-e031-245e-e053-6294a90addb5 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83455-201-01 | Cough Drops | 200 in 1 BAG | PASTILLE | 200 | 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 |
|---|---|---|---|---|---|---|
| Exchange Select Nasal | OXYMETAZOLINE HCL | Army & Air Force Exchange Service | 40d2090d-c332-4dcb-9f43-5ee467e7b3d1 | 2024-08-27 | Warnings | M012 |
| Signature Care Nasal Decongestant | OXYMETAZOLINE HCL | Safeway | 23f0a5b3-59ae-4eb3-9b7d-e6a492060337 | 2024-08-27 | Warnings | M012 |
| DG Health Nasal | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | debcda99-c605-4941-b873-9e4dbae27483 | 2024-08-27 | Warnings | M012 |
| Good Neighbor Pharmacy Nasal | OXYMETAZOLINE HCL | Amerisource Bergen | d374d697-2b57-4558-a20b-d3d89aea82d7 | 2024-08-27 | Warnings | M012 |
| nasal | OXYMETAZOLINE HCL | Meijer Distribution Inc | 3984cbc3-b60c-40a7-bc3a-7d1f600503ac | 2024-08-27 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Strategic Sourcing Services LLC | e6e51821-03ae-4ec3-82a9-b4a8feacd996 | 2024-08-27 | Warnings | M012 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | Westminster Pharmaceuticals, LLC | dd068449-9d24-41e6-8a6e-f69c9fe263f2 | 2024-08-26 | Warnings | M012 |
| basic care nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | a154e500-2b45-4242-a26c-9530849f99df | 2024-08-23 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0c0cf76f-2dd3-45ef-e063-6394a90a9fef | 2024-08-22 | Warnings | M012 |
| Day Cold and Flu and Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | TARGET CORPORATION | 08ee56d1-b11d-3e36-e063-6294a90acd5f | 2024-08-22 | Warnings | M012 |
| Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE | TARGET CORPORATION | 0fc523ce-55a7-6384-e063-6394a90aad3f | 2024-08-22 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreens | 8045aef9-22bc-4146-b494-dbb1ffef06df | 2024-08-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 5a2053d4-9c0d-4613-9cf5-0067173f3730 | 2024-08-16 | Warnings | M012 |
| QUALITY CHOICE Long Acting Cough Softgel | DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Marketing Association, Inc. | f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c | 2024-08-16 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Padagis Israel Pharmaceuticals Ltd | 458594e1-8d99-4de3-8923-2fd8ce2fc406 | 2024-08-16 | Warnings | M012 |
| Halls Sugar Free Mountain Menthol | MENTHOL | Mondelez Global LLC | 54e0d57e-1f48-45e2-86b3-0e50775996f4 | 2024-08-15 | Warnings | M012 |
| SanaTos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 1fc1408c-c540-39ab-e063-6394a90aa477 | 2024-08-15 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 489645ad-d7da-5f52-e054-00144ff8d46c | 2024-08-14 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 6c949602-e0c8-40ce-8fb3-5147f406fa04 | 2024-08-14 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 3dbdf020-ca17-1197-e054-00144ff8d46c | 2024-08-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 476973 | menthol 5.8 MG Oral Lozenge | PSN | f9f0d020-e031-245e-e053-6294a90addb5 | 2 |
| 476973 | menthol 5.8 MG Oral Lozenge | SCD | f9f0d020-e031-245e-e053-6294a90addb5 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83455-201-01 | 83455020101 | 200 PASTILLE in 1 BAG (83455-201-01) | 200 pastille | 2023-05-12 | No | No | Current |