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 |
|---|---|---|---|---|---|---|
| Cold and Allergy | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DOLGENCORP, LLC | b55452e1-25d0-4db5-9621-83f21ec6c298 | 2026-04-06 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Strategic Sourcing Services LLC | c9fa8d93-d9d6-4206-a13d-32b9e7555e7f | 2026-04-02 | Warnings | M012 |
| Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 6aaed3fe-ce35-4533-aea4-80096ce8e57a | 2026-04-02 | Warnings | M012 |
| Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 19879fc8-4962-4c6e-87ed-b874d1d564af | 2026-04-01 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Lidl US LLC | 7227b330-590b-4731-8a58-e05a0233dd8a | 2026-04-01 | Warnings | M012 |
| SudoGest | CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | 7cd8f7f3-c262-4f7c-bcaf-068be2c952f9 | 2026-04-01 | Warnings | M012 |
| Sanatos Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 4c26be18-733a-e4a8-e063-6294a90a8b02 | 2026-04-01 | Warnings | M012 |
| Sanatos Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 4c26c8bf-0143-ddca-e063-6294a90a3552 | 2026-04-01 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Method Pharmaceuticals, LLC | fe126254-6ee6-48c3-965c-96e4276a5314 | 2026-04-01 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief | GUAIFENESIN | AmerisourceBergen Drug Corp | 200dddd9-e3ff-4cec-a164-d1c9a698f121 | 2026-03-31 | Warnings | M012 |
| Head and Cold | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Hi-Tech Nutraceuticals, LLC | a39c772b-3cce-14cb-e053-2a95a90a733b | 2026-03-31 | Warnings | M012 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 44217a8c-7656-a0f6-e063-6294a90af2ad | 2026-03-31 | Warnings | M012 |
| Dr Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CalmCo LLC | 3f156679-7a91-aff1-e063-6394a90a18f6 | 2026-03-31 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | A-S Medication Solutions | c26da6e0-ab1c-46c2-acf5-0074958c03cd | 2026-03-31 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | ba174fcc-da1e-420c-bf9c-179ad65c2848 | 2026-03-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Amerisource Bergen | 8e0c6f8d-559c-45de-9362-1b713fd78a7a | 2026-03-30 | Warnings | M012 |
| Dr. Simi Daytime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG | Farmacias De Similares TX LLC | 4e448fd0-cb6b-b69b-e063-6394a90afde8 | 2026-03-30 | Warnings | M012 |
| Dr. Simi Nighttime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG | Farmacias De Similares TX LLC | 4e5772ee-586c-6191-e063-6294a90a132d | 2026-03-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HCL | HyVee Inc | 75b19163-db1c-42fc-8bbb-364be16b9b2f | 2026-03-30 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | a9f23c63-eeda-4de9-aec6-fe482f469e98 | 2026-03-27 | 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 |