BRONCOLIN
- Product NDC
- 62583-010
- 11-digit product format
- 625830010
- Labeler code
- 62583
- Product ID
- 62583-010_eb01a962-ab3a-18ec-e053-2995a90acdeb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- BRONCOLIN, S.A. de C.V.
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-04-01
- Marketing end
- 0000-00-00
- Substance
- MENTHOL
- Active strength
- 8 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 62583-010 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 62583-010 | 62583-010-22 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 62583-010-22 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 62583-010-22 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 62583-010-22 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 62583-010-22 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 62583-010-22 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 62583-010-22 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 62583-010-22 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 62583-010-22 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 62583-010-22 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 62583-010-22 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 62583-010-22 | 367a005e9d99… | 383a685ebd0f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| AXIV DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 131b1f17-cd86-f9b3-e063-6294a90a3028 | 2025-02-12 | Warnings | M012 |
| Maximum Strength Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates, LLC | 17d0dbc7-c8c2-7917-e063-6394a90a42af | 2025-02-12 | Warnings | M012 |
| DAYTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Kroger Company | bc00bbf8-52bb-fa75-e053-2a95a90a9406 | 2025-02-11 | Warnings | M012 |
| Daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS | TIME CAP LABORATORIES, INC. | fd24653e-c4fa-3c09-e053-6394a90aaa9e | 2025-02-10 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS | TIME CAP LABORATORIES INC. | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2025-02-10 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | DOLGENCORP, LLC | be2207b7-b8f8-7fba-e053-2a95a90abd16 | 2025-02-10 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Kroger Company | bc0115a3-5322-855d-e053-2995a90aba27 | 2025-02-10 | Warnings | M012 |
| Day time high blood pressure cold and flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Camber Consumer Care | 09fbd872-0970-4864-9308-4a7b85983920 | 2025-02-10 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f05e11ce-c908-acbc-e053-2a95a90a584e | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f035c499-cda6-fadf-e053-2995a90af457 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6d977ce-bbca-f1cc-e053-6394a90acc96 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6da36d3-496d-2336-e053-6394a90a0f83 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6da2e02-42c7-1ede-e053-6394a90aff5f | 2025-02-09 | Warnings | M012 |
| MUCOSA DM | GUAIFENESIN DEXTROMETHORPHAN | TIME CAP LABORATORIES, INC. | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 2025-02-08 | Warnings | M012 |
| Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | 2d95d5a4-34dc-e195-e063-6394a90a39da | 2025-02-07 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 5d56ccd2-1c28-4750-9454-44809091ad2f | 2025-02-05 | Warnings | M012 |
| SanaTos Mucus Relief Cold Toddlers | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 60672feb-1421-651e-e053-2a91aa0af41d | 2025-02-04 | Warnings | M012 |
| SofSkin Vaporizing Chest Rub and Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Viny Health and Beauty Inc | 34626cf5-64fc-15c0-e063-6294a90aa310 | 2025-02-04 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY, INC | 17922df7-7867-4300-bd99-55aee7b60606 | 2025-02-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | f4b8ff54-47b5-4d18-bf4e-b101abb22a24 | 2025-02-03 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62583-010-22 | 62583001022 | 22 LOZENGE in 1 BAG (62583-010-22) | 22 lozenge | 2015-04-01 | 0000-00-00 | No | No | Current |