ACTIDOM DMX
- Product NDC
- 63102-110
- 11-digit product format
- 631020110
- Labeler code
- 63102
- Product ID
- 63102-110_07838a85-4ddc-470d-a344-001587f2d904
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ACTIPHARMA, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-08-13
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 30; 200; 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- ACTIDOM DMX
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
| GUAIFENESIN | 200 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1364914 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0166322e-7dbb-4658-a5c5-1d0525bb7655 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63102-110-16 | ACTIDOM DMX | 474 mL in 1 BOTTLE, PLASTIC | SOLUTION | 474 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63102-110-16 | ML - Milliliter | 63102-110 | 7833e864-0a75-4985-8c27-6a061c163ead | 1 | 2015-12-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63102-110 | ACTIDOM DMX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240809_0166322e-7dbb-4658-a5c5-1d0525bb7655.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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f40bfdfc-1cb4-4604-9790-fb8d1d5173c6 | 2025-01-31 | Warnings | M012 |
| NIGHTIME COLD AND FLU | NIGHTIME COLD AND FLU | TARGET CORP | 9dee9b92-eac9-b07d-e053-2995a90a0602 | 2025-01-31 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Bryant Ranch Prepack | 7b23faa9-40c8-4cea-b9fb-487cce2664af | 2025-01-31 | Warnings | M012 |
| BENADRYL Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 224ba2a3-1a93-29c8-e063-6394a90a9bef | 2025-01-30 | Warnings | M012 |
| Extra Strength Nite-Time Pain Relief | 430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET | WALGREENS | c25cff5a-93f5-62aa-e053-2a95a90aa7b4 | 2025-01-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALGREENS | dbf5c814-4e69-13ac-e053-2a95a90a49a3 | 2025-01-30 | Warnings | M012 |
| Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | WALGREENS | f3770976-de73-52b8-e053-2995a90aad4f | 2025-01-30 | Warnings | M012 |
| Dextromethorphan HBr and Guaifenesin Oral Solution | DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION | KESIN PHARMA CORPORATION | 284eae44-81bc-400c-e063-6394a90af446 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26c82bc3-5753-4d56-96a4-a3f9c8c267d0 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8095b211-8ae7-44e5-b89a-b7f730e28d51 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2cf2f35b-5d59-e3ff-e063-6294a90a9b45 | 2025-01-30 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy, Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5 | 2025-01-30 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | RB Health (US) LLC | 2ce20ab5-5f2d-1c97-e063-6394a90ad67b | 2025-01-29 | Warnings | M012 |
| Guaifenesin and Dextromethorphan | GUAIFENESIN AND DEXTROMETHORPHAN | Major Pharmaceuticals | 97b137c9-0bec-409a-91f7-e298c296578b | 2025-01-29 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS | 1dc17665-62ce-f7f5-e063-6294a90af851 | 2025-01-29 | Warnings | M012 |
| UP AND UP NO DRIP NASAL | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 760d6d0f-00fc-40bc-858d-83a0827d139f | 2025-01-29 | Warnings | M012 |
| Guaifenesin and Dextromethorphan | GUAIFENESIN AND DEXTROMETHORPHAN | Major Pharmaceuticals | 51e48201-bb62-4e89-85eb-e4a416f93522 | 2025-01-29 | Warnings | M012 |
| Severe Congestion and Cough Max | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice | 8c878e47-94f4-484f-bdd8-6d87ac2440d8 | 2025-01-28 | Warnings | M012 |
| Cough and Cold Therapy | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088be461-7afc-586a-e063-6294a90a700b | 2025-01-27 | Warnings | M012 |
| Cough and Cold Therapy For Kids | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088df369-114c-db4f-e063-6394a90acfac | 2025-01-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1364914 | dextromethorphan HBr 30 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 4 |
| 1364914 | dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 4 |
| 1364914 | dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution | SY | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63102-110-16 | 63102011016 | 474 mL in 1 BOTTLE, PLASTIC (63102-110-16) | 474 ml | 2015-08-13 | 0000-00-00 | No | No | Current |