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 | 2026-10-12 | ||
| excluded package | package | 62583-010 | 62583-010-22 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| Dollar General | NASAL PHENYLEPHRINE HYDROCHLORIDE | DOLGENCORP, INC. (DOLLAR GENERAL & REXALL) | e8fd3f0e-a023-4423-8906-17ae02bc083b | 2026-09-03 | Warnings | M012 |
| Mucus Relief Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | TARGET Corporation | 1bf9a59e-cc37-4780-ba75-7138c546eb19 | 2026-09-02 | Warnings | M012 |
| Childrens Multi Symptom Fever and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | THE KROGER CO. | 3daf7620-eb57-43d5-ba88-938b7221e346 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | 69fd13a1-2b76-8574-e053-2a91aa0a27e7 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp. | a6880389-0dc1-43a7-a73b-77f77bafe51e | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | fa8510d8-d50a-4743-ba87-a12e9ab43125 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | dfcf1231-8271-458d-b375-e328d6fd4e9b | 2026-09-02 | Warnings | M012 |
| Nighttime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Shield Pharmaceuticals Corp | decafa3a-3734-4161-bab0-121945881846 | 2026-09-02 | Warnings | M012 |
| Kroger Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | KROGER COMPANY | 1ff037ea-1a3b-430a-be31-2e240cc3b6f3 | 2026-09-02 | Warnings | M012 |
| KROGER Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | KROGER COMPANY | 79d24014-1af7-4d62-bcb8-5bea76a7d6ee | 2026-09-02 | Warnings | M012 |
| Kroger No Drip | ALLERGY SINUS | KROGER COMPANY | 4788bafb-8866-4a0a-b217-226513799c24 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | e1d27123-358f-4b0c-8e3b-33474750a0e6 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Nighttime Cold and Flu | ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL | THE KROGER CO | 058b2021-8a61-40b0-8a2e-a784d2b847fb | 2026-09-02 | Warnings | M012 |
| KROGER Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2bea22e9-34b6-4961-94bb-5600dd90e891 | 2026-09-02 | Warnings | M012 |
| KROGER No Drip Nasal Mist Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | KROGER COMPANY | 7256e048-ad69-4322-844d-872f05e6fc8a | 2026-09-02 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | The Kroger Co. | 494e69ef-dc9f-4e14-b856-5eaf0f541a03 | 2026-09-02 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM Sugar Free | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | 5c4c8115-cec9-4f2c-9ea9-328535e97b07 | 2026-09-01 | Warnings | M012 |
| MAX ALLERGY KIDS | DIPHENHYDRAMINE HCL | Akron Pharma Inc. | 96c4ade8-67b1-41e5-8624-fb49090208af | 2026-09-01 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE | HEXYLRESORCINOL AND MENTHOL | Reckitt Benckiser LLC | 4a938e15-a996-8538-e063-6294a90ad4ee | 2026-09-01 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | WALMART INC. | 5e6623c3-6210-4c50-94d6-5554f36876d1 | 2026-08-31 | 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 |