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 |
|---|---|---|---|---|---|---|
| sinus pressure and pain pe | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a7931e4c-8a5e-66e2-e053-2995a90af2a4 | 2024-10-18 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 570ea130-6a99-446e-9f97-14fc95809006 | 2024-10-18 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a14999e3-a9d9-0a1f-e053-2995a90af7b3 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a793000b-3ef9-5662-e053-2a95a90ad0da | 2024-10-18 | Warnings | M012 |
| Cold Multi-Symptom Daytime and Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 37455f86-ab21-472b-9e80-40324699f3ca | 2024-10-18 | Warnings | M012 |
| Head Congestion Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3396a27-8643-71fa-e053-2a95a90a713d | 2024-10-18 | Warnings | M012 |
| Head Congestion Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3397f69-3267-ca0b-e053-2995a90a7db5 | 2024-10-18 | Warnings | M012 |
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 747512a2-3b6d-496b-ab80-819060314163 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 9daf7f40-d9c5-4367-be41-894208358fc1 | 2024-10-18 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 608e6808-29e4-40bc-8496-24c092681a1b | 2024-10-18 | Warnings | M012 |
| Cold Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 665db127-ee04-46c4-bff0-e0fe9950c3e2 | 2024-10-18 | Warnings | M012 |
| Cold Max Day and Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8 | 2024-10-18 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 604d7e53-4bfd-4cdd-aed2-b304ae82ce44 | 2024-10-18 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | DISCOUNT DRUG MART | 4d93a703-c905-4fb3-b772-11c207065d4d | 2024-10-17 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 62c35320-87b5-46e2-9f6f-cb0882bdb52e | 2024-10-17 | Warnings | M012 |
| Cold Max Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3dcf6cf-373c-ea83-e053-2a95a90ae57a | 2024-10-17 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e99dad-5918-6a90-e053-2a95a90a8803 | 2024-10-17 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e99dad-5916-6a90-e053-2a95a90a8803 | 2024-10-17 | Warnings | M012 |
| ALLERGY MULTISYMPTOM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e9ab8e-2252-180d-e053-2a95a90a788f | 2024-10-17 | Warnings | M012 |
| COLD PLUS HEAD CONGESTION SEVERE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 3430c7e4-e142-407e-bed5-358dd6bd10f7 | 2024-10-17 | 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 |