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 |
|---|---|---|---|---|---|---|
| MGC Health | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f3f6dd-751d-1dfe-e063-6394a90a0dbb | 2026-03-25 | Warnings | M012 |
| MGC Health | COUGH DROPS MENTHOL SUGAR-FREE | Medical Group Care LLC | f4a90af2-47af-ac8c-e053-2a95a90ab97e | 2026-03-25 | Warnings | M012 |
| MGC Health | COUGH DROPS BLACK CHERRY SUGAR FREE | Medical Group Care LLC | 043b3639-ab38-adff-e063-6394a90a2ade | 2026-03-25 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE | WinCo Foods, LLC | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 2026-03-25 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 3e73a5f7-5976-4839-9705-c1730ff6bf30 | 2026-03-25 | Warnings | M012 |
| GOOD SENSE TUSSIN | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | L. Perrigo Company | 5fb96638-a9bc-4be6-a624-da303a9e98a3 | 2026-03-25 | Warnings | M012 |
| Cold and Flu Relief Multi symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | WinCo Foods, LLC | 9beeeb3b-6b26-4b9a-843b-ce3658d1debe | 2026-03-25 | Warnings | M012 |
| Nighttime Cold and Flu Relief | NIGHTTIME COLD AND FLU RELIEF | Grocery Outlet | a58459e3-6ada-4d99-9e22-1a0107676151 | 2026-03-25 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG | Grocery Outlet | 2f90dfb6-4257-44a8-a685-1873645d1c96 | 2026-03-25 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Grocery Outlet, Inc. | 4d887ed0-4532-5125-e063-6394a90ac44d | 2026-03-24 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS HEALTH CORP | 2ba90b91-2e35-4701-e063-6294a90a7554 | 2026-03-24 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN 400 MG | TWIN MED LLC | e31bd69f-97ab-9d99-e053-2995a90a580e | 2026-03-24 | Warnings | M012 |
| Severe Sinus Congestion and Pain Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | b7b1c3cc-fdf3-4e75-8c3f-2e832f09a887 | 2026-03-24 | Warnings | M012 |
| Nuvicare Long-Acting Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | NUVICARE LLC | ec1d3dd6-2a8b-4487-81a2-be6313e97610 | 2026-03-24 | Warnings | M012 |
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | ed28bfa9-3768-4f42-ae5e-1c527b4456d1 | 2026-03-24 | Warnings | M012 |
| Gencare Long-Acting Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | PIONEER LIFE SCIENCES, LLC | 7a02cbb6-c083-4d91-977b-9d53cb3e2784 | 2026-03-24 | Warnings | M012 |
| Sinus Severe Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | b65baa7c-8197-4361-b3ef-e60eba38dca1 | 2026-03-24 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | e9a53a2c-c5e8-48ba-97d9-c1e3cbd8da4b | 2026-03-24 | Warnings | M012 |
| Mucus Relief Congestion and Headache Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2638b541-e680-4949-a7c7-fcee165cbc92 | 2026-03-23 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 778dc0fb-30c3-4fbf-856a-7bca28181b39 | 2026-03-23 | 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 |