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 |
|---|---|---|---|---|---|---|
| Viva Porru Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Menper Distributors, Inc. | 0dfadfe3-9e40-0eee-e063-6294a90a00c3 | 2025-07-22 | Warnings | M012 |
| leader childrens allergy relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. dba Leader | 40d697b7-dc59-4d24-8d46-db635e01b9d5 | 2025-07-22 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Chain Drug Consortium | 34005c55-3176-4f28-9a3b-7dc6fefd01fe | 2025-07-19 | Warnings | M012 |
| Sinus Relief Daytime Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 73a77a13-983b-4e65-bb3c-2ba5e9f33a3e | 2025-07-19 | Warnings | M012 |
| QUALITY CHOICE No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 7cb6ad04-7847-46b9-b371-0a3473001c79 | 2025-07-18 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Chain Drug Consortium | 270e9221-d305-4148-b523-741e02fe733f | 2025-07-18 | Warnings | M012 |
| ACTISPEC PSE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 5def1555-87f4-41d5-8a5c-be560aa8f1e2 | 2025-07-17 | Warnings | M012 |
| EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 1a17b24a-8022-4e2f-e063-6294a90af276 | 2025-07-17 | Warnings | M012 |
| BULPOL Smoking Patches | MENTHOL | Jiashen International Trade Limited | 3a1cc0e1-fabf-52b9-e063-6394a90ae35e | 2025-07-17 | Warnings | M012 |
| Ampigrin Ultra Forte Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | e11e71c3-fe7c-77c7-e053-2995a90a34b2 | 2025-07-17 | Warnings | M012 |
| Nitecin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | dfb56532-6f72-1e4d-e053-2a95a90a1c05 | 2025-07-17 | Warnings | M012 |
| tabcin NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | 0b3ed2bb-88ed-699e-e063-6394a90ac023 | 2025-07-17 | Warnings | M012 |
| Pentrexcilina Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | e11e5c17-28f2-7186-e053-2995a90a51f6 | 2025-07-17 | Warnings | M012 |
| Viro Flu PM Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | e1553da8-3a89-e258-e053-2a95a90a4725 | 2025-07-17 | Warnings | M012 |
| ACTICON PEDIATRIC | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23 | 2025-07-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Demoulas Super Markets, Inc | 397f5acd-31c0-683e-e063-6394a90a7e54 | 2025-07-16 | Warnings | M012 |
| EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 2025-07-16 | Warnings | M012 |
| DG HEALTH COLD FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 8ea03891-2fbc-4413-8e6d-de903d426f8d | 2025-07-16 | Warnings | M012 |
| up and up nighttime flu and severe cold and cough | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | df488727-b913-440b-9a0b-cce3ae143bf2 | 2025-07-15 | Warnings | M012 |
| Topcare DayTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | bb9663e3-fd11-4e72-bf85-fee4841b795f | 2025-07-15 | 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 |