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 |
|---|---|---|---|---|---|---|
| Cold Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 077fac1a-0ec5-40d9-8861-a281b48f650a | 2026-09-08 | Warnings | M012 |
| Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | RARITAN PHARMACEUTICALS | eef00453-9f4f-4a05-bb4e-49b94705b52c | 2026-09-08 | Warnings | M012 |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | RARITAN PHARMACEUTICALS INC | 9819155b-2713-42be-867e-16605e7643d0 | 2026-09-08 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | WALMART INC. | f9d1dfd1-527f-491d-9188-14886ac70ced | 2026-09-08 | Warnings | M012 |
| severe cold and cough daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | RARITAN PHARMACEUTICALS INC | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 2026-09-08 | Warnings | M012 |
| Multi Symptom Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS INC | d9606c9a-31b1-4121-9870-809a05f5b68a | 2026-09-08 | Warnings | M012 |
| Mucus Relief DM Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | RARITAN PHARMACEUTICALS INC | 4898b1c2-55ef-4589-982b-2279c01707e5 | 2026-09-08 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association, Inc. | 2a7afe03-3c34-4e30-827e-b3bb2568cb97 | 2026-09-08 | Warnings | M012 |
| tabcin Extra Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | OPMX LLC | 23223821-4fa0-5d99-e063-6394a90af0e5 | 2026-09-07 | Warnings | M012 |
| Drx Choice childrens allergy chews | DIPHENHYDRAMINE HCL | RARITAN PHARMACEUTICALS INC | dd2be906-bd0a-437c-9693-54b9391a5da3 | 2026-09-05 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 49235f4f-e661-4a83-88ef-b9a956848777 | 2026-09-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 71845bf9-8981-4ca0-a62c-dbef102b1b02 | 2026-09-04 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 774d2bde-9f57-4ced-800a-cada39c685ed | 2026-09-04 | Warnings | M012 |
| Nostrilla | OXYMETAZOLINE HYDROCHLORIDE | Insight Pharmaceuticals LLC | 86217847-8e2b-48cc-b289-4987fd3aa7c3 | 2026-09-04 | Warnings | M012 |
| tussin cough chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rite Aid Corporation | 86fc3723-5fc5-4de5-bd04-7774c2abe539 | 2026-09-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | ed576bf1-3949-423e-af2e-e4b1a3839b21 | 2026-09-04 | Warnings | M012 |
| tussin nighttime cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 80d51af8-3a7b-4d22-8d4f-df5f91913047 | 2026-09-04 | Warnings | M012 |
| NO MORE NOSEBLEED | OXYMETAZOLINE HYDROCHLORIDE | DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. | 69d3f1fe-b476-4f84-8c5e-94957b74b46c | 2026-09-04 | Warnings | M012 |
| Ultra Fine Mist Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | DOLGENCORP, INC. | 5f134840-2465-4585-a85d-08d746f76f7a | 2026-09-03 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE | Family Dollar (FAMILY WELLNESS) | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 2026-09-03 | 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 |