Mielim y mas
- Product NDC
- 58593-295
- 11-digit product format
- 585930295
- Labeler code
- 58593
- Product ID
- 58593-295_24701771-2c31-2dfd-e063-6394a90a99db
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Efficient Laboratories Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1997-02-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 15 mg/5mL
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 58593-295 | 58593-295-04 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Mielim y mas
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 711d1dae-3af4-46af-a3a8-cd827356a81a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 58593-295-04 | 2020-02-18 | Drug Facts |
| 58593-295-06 | 2020-02-18 | Drug Facts |
| 58593-295-04 | 2020-01-31 | Drug Facts |
| 58593-295-06 | 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-295-04 | Mielim y mas | 118 mL in 1 BOTTLE | LIQUID | 118 | 8 | |
| 58593-295-06 | Mielim y mas | 178 mL in 1 BOTTLE | LIQUID | 178 | 8 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 3862aaa5-2281-e8f9-e063-6294a90a0f7e | 2025-09-09 | Warnings | M012 |
| McKesson Sugar Free Cough Suppressant Oral Anesthetic | MENTHOL LOZENGE | McKesson Medical-Surgical | e0dfa6ca-b311-25cb-e053-2a95a90a12cc | 2025-09-09 | Warnings | M012 |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e648f017-9e30-df6c-e053-2995a90adcd0 | 2025-09-09 | Warnings | M012 |
| Medi-First Honey Lemon Cough Drops | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 826e1b87-e5a9-8637-e053-2991aa0aded1 | 2025-09-09 | Warnings | M012 |
| Unishield Cherry Cough | MENTHOL | Unishield | b8297bc1-44b2-3de0-e053-2995a90ad01b | 2025-09-09 | Warnings | M012 |
| McKesson Cough Supressant | MENTHOL | McKesson Medical-Surgical | db5e0490-2ed8-2d53-e053-2a95a90a98f5 | 2025-09-09 | Warnings | M012 |
| Duratuss AC | CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 3e5ed178-d5d9-b8d4-e063-6394a90a91db | 2025-09-09 | Warnings | M012 |
| Rompe Pecho CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Efficient Laboratories Inc | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 57c458ed-7987-453b-ab24-bbfa6580f920 | 2025-09-09 | Warnings | M012 |
| equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 38637189-d1ee-9405-e063-6394a90ae8b8 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | fd52d8d8-7cd1-4e92-86da-354a1d5213c2 | 2025-09-08 | Warnings | M012 |
| Green Guard Advanced Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e8e5fb21-a7fd-44d1-b9c4-83e949699ca6 | 2025-09-08 | Warnings | M012 |
| Medi-First Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9654f5cd-74d7-44a2-9674-666d1e94ffa7 | 2025-09-08 | Warnings | M012 |
| Otis Clapp Mygrex | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | f196f2c5-a100-42b1-bd01-0327b223838e | 2025-09-08 | Warnings | M012 |
| Medique Diphen | DIPHENHYDRAMINE HYDROCHLORIDE | Unifirst First Aid Corporation | b61ee2e0-2543-447d-9fc4-23363d46ce04 | 2025-09-08 | Warnings | M012 |
| Green Guard Allergy 2 Relief | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 16fddca9-a66b-41e6-9423-eaf091d3971e | 2025-09-08 | Warnings | M012 |
| Medique Medi-Phenyl | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | d7d62ac1-1333-4366-884b-26537766ce38 | 2025-09-08 | Warnings | M012 |
| Unishield Sinus Decongestant | PHENYLEPHRINE HCL | Unishield | b8f68d9d-2d38-414a-e053-2a95a90a15ec | 2025-09-08 | Warnings | M012 |
| McKesson Sinus Pain and Pressure Relief | ACETAMINOPHEN, PHENYLEPHRINE HCL | McKesson Medical-Surgical | e0cbb213-4f4f-4045-e053-2a95a90a2a18 | 2025-09-08 | Warnings | M012 |
| Medique Medicidin D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 1f172d58-4050-424b-9743-130d8e618fe8 | 2025-09-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1090496 | dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
| 1099285 | Mielim y mas 15 MG in 5 mL Oral Solution | PSN | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
| 1099285 | dextromethorphan hydrobromide 3 MG/ML Oral Solution [Mielim Y Mas] | SBD | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
| 1090496 | dextromethorphan hydrobromide 3 MG/ML Oral Solution | SCD | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
| 1090496 | dextromethorphan hydrobromide 15 MG per 5 ML Oral Solution | SY | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
| 1090496 | dextromethorphan hydrobromide 30 MG per 10 ML Oral Solution | SY | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
| 1099285 | Mielim Y Mas 15 MG per 5 ML Oral Solution | SY | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
| 1099285 | Mielim Y Mas 3 MG/ML Oral Solution | SY | 711d1dae-3af4-46af-a3a8-cd827356a81a | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58593-295-04 | 58593029504 | 118 mL in 1 BOTTLE (58593-295-04) | 118 ml | 1997-02-01 | 0000-00-00 | No | No | Current |
| 58593-295-06 | 58593029506 | 178 mL in 1 BOTTLE (58593-295-06) | 178 ml | 1997-02-01 | 0000-00-00 | No | No | Current |