M-END
- Product NDC
- 12830-816
- 11-digit product format
- 128300816
- Labeler code
- 12830
- Product ID
- 12830-816_413d30e9-616e-f896-e063-6394a90acebc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- R. A. McNeil Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-10-13
- Substance
- DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- .667; 10; 20 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 12830-816-16 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 12830-816-30 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 12830-816-16 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 12830-816-30 | fb8cb913e6d1… | eb8c232b6be0… |
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
- M-END
- Brand name suffix
- DMX
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXBROMPHENIRAMINE MALEATE | .667 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 20 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BPA9UT29BS | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 6V9V2RYJ8N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1190600 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ee1fae2e-3a21-4487-9989-c7620a4a7056 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 12830-816-16 | 2024-03-19 | M-END DMX |
| 12830-816-16 | 2024-03-19 | M-END DMX |
| 12830-816-30 | 2024-03-19 | M-END DMX |
| 12830-816-30 | 2024-03-19 | M-END DMX |
| 12830-816-16 | 2024-01-30 | M-END DMX |
| 12830-816-16 | 2024-01-30 | M-END DMX |
| 12830-816-30 | 2024-01-30 | M-END DMX |
| 12830-816-30 | 2024-01-30 | M-END DMX |
| 12830-816-16 | 2022-12-22 | M-END DMX |
| 12830-816-16 | 2022-12-22 | M-END DMX |
| 12830-816-30 | 2022-12-22 | M-END DMX |
| 12830-816-30 | 2022-12-22 | M-END DMX |
| 12830-816-16 | 2022-07-29 | M-END DMX |
| 12830-816-16 | 2022-07-29 | M-END DMX |
| 12830-816-30 | 2022-07-29 | M-END DMX |
| 12830-816-30 | 2022-07-29 | M-END DMX |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12830-816-16 | M-ENDDMX | 473 mL in 1 BOTTLE | LIQUID | 473 | 9 | |
| 12830-816-30 | M-ENDDMX | 30 mL in 1 BOTTLE | LIQUID | 30 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 12830-816-16 | ML - Milliliter | 12830-816 | 7caf2d65-b241-4862-9fda-e1c89f90c2c2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 12830-816 | M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240321_ee1fae2e-3a21-4487-9989-c7620a4a7056.zip |
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 |
|---|---|---|---|---|---|---|
| Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief | CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | WAL-MART STORES,INC. | 68a68574-0fcb-4569-be57-d9aee5f62bea | 2025-10-28 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 635009a1-6154-4c62-a4be-d4f32c2cef8d | 2025-10-28 | Warnings | M012 |
| Publix Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | cf49a06d-f095-48bf-bcd2-a410066ff9af | 2025-10-28 | Warnings | M012 |
| Publix | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | 283e42b9-173c-4deb-9377-ff649efc177f | 2025-10-28 | Warnings | M012 |
| Publix Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | eae83b75-9d5a-4100-9304-629e54ef7752 | 2025-10-28 | Warnings | M012 |
| Publix | PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | f10e120d-f0b7-4c51-b29b-e8cdbb1456f3 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0f8e9e-0503-522b-e053-2a91aa0aca35 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0eef2f-f546-d769-e053-2991aa0a8fe4 | 2025-10-28 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | P & L Development, LLC | 4af67ba7-8892-442c-b9fb-80aba9140e05 | 2025-10-28 | Warnings | M012 |
| No Drip Nasal Mist Nasal Decongestant Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 994fa270-65bb-4097-b88a-d5ce3c0e1c79 | 2025-10-27 | Warnings | M012 |
| Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | WAL-MART STORES INC. | 3652ee94-b762-4100-a305-5acbec5f795a | 2025-10-27 | Warnings | M012 |
| Maximum Strength Mucus Relief Cold,Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | Wal-Mart Stores,Inc., | 2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc | 2025-10-27 | Warnings | M012 |
| Allergies MY CHILD NEEDS HELP WITH | DIPHENHYDRAMINE HCL | Unconditional Love | 5ad293e9-0a4b-4923-8a91-f01450726828 | 2025-10-27 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Amazon.com Services LLC | 4a9fd615-b7d3-452c-ac40-d9189124faaa | 2025-10-24 | Warnings | M012 |
| allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | 622b12fa-455c-4432-a9a2-698a929bbd68 | 2025-10-24 | Warnings | M012 |
| Dristan 12 hr | OXYMETAZOLINE HYDROCHLORIDE | Foundation Consumer Brands | 522876fe-a412-4ca8-bfad-a313e3cbc1af | 2025-10-24 | Warnings | M012 |
| Dimetapp Multi-Symptom Cold and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 178fe95b-e1ed-43b2-e063-6294a90a7a78 | 2025-10-24 | Warnings | M012 |
| Menthol Drops Dollar General Severe 45ct | MENTHOL | Dollar General Corporation | c831d3d9-b910-40e6-bfdf-defe6850614d | 2025-10-24 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 7d2f3292-bb73-41dc-9729-edb83670be1b | 2025-10-24 | Warnings | M012 |
| Freegells Cough Drops Menthol 30ct | MENTHOL | R.L. ALBERT & SON, INC | b174e57c-4e4f-4842-b8f2-f1b067764a68 | 2025-10-24 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190600 | dexbrompheniramine maleate 0.667 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 20 MG in 5 mL Oral Solution | PSN | ee1fae2e-3a21-4487-9989-c7620a4a7056 | 9 |
| 1190600 | dexbrompheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 4 MG/ML Oral Solution | SCD | ee1fae2e-3a21-4487-9989-c7620a4a7056 | 9 |
| 1190600 | dexbrompheniramine maleate 0.667 MG / dextromethorphan hydrobromide 10 MG / pseudoephedrine hydrochloride 20 MG per 5 ML Oral Solution | SY | ee1fae2e-3a21-4487-9989-c7620a4a7056 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 12830-816-16 | 12830081616 | 473 mL in 1 BOTTLE (12830-816-16) | 473 ml | 2011-10-13 | 0000-00-00 | No | No | Current |
| 12830-816-30 | 12830081630 | 30 mL in 1 BOTTLE (12830-816-30) | 30 ml | 2011-10-13 | 0000-00-00 | No | No | Current |