ACTINEL DM Pediatric
- Product NDC
- 63102-130
- 11-digit product format
- 631020130
- Labeler code
- 63102
- Product ID
- 63102-130_e0485b3d-5021-4c2e-aa88-b10bcc2511a5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- ACTIPHARMA, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-12
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; 75; 2.5 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
- ACTINEL DM Pediatric
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| GUAIFENESIN | 75 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 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 |
|---|---|
| 1119541 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63102-130-16 | ACTINEL DM Pediatric | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | 1 |
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 |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 50762d7c-5efd-4f83-e063-6294a90abf7f | 2026-04-27 | Warnings | M012 |
| Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 6427b418-89d1-4eac-b25b-0adfefc204fc | 2026-04-27 | Warnings | M012 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (American Sales Company) | bd5de3b3-7cb5-4403-b664-23ac70b9957f | 2026-04-27 | Warnings | M012 |
| Leader Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | 333c7042-95b8-4d98-9df1-4287017afa36 | 2026-04-25 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f2d55d1b-c3d4-4c35-b761-681ed50273bd | 2026-04-24 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Sportpharm LLC | 2c4e0d5e-958d-4274-876a-52126c795c0f | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50364a42-3333-51fe-e063-6394a90ab71e | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5036dc50-e95b-ea8d-e063-6394a90a6cfe | 2026-04-24 | Warnings | M012 |
| Cold and Flu Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dcb33d5f-87fa-4043-9b6d-36adec96796c | 2026-04-24 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Cardinal Health 107, LLC | abc0e348-8532-4658-bd8c-d7dbe5a28c7d | 2026-04-23 | Warnings | M012 |
| nitetime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | c5535aaf-c029-48d8-97d1-105a49b5fd95 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | 50228b3c-d54a-485d-e063-6394a90a4403 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5025a333-6378-bf59-e063-6394a90af4f0 | 2026-04-23 | Warnings | M012 |
| POLY-HIST DM | DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR | POLY PHARMACEUTICALS, INC. | 5025c99f-b946-e2e0-e063-6394a90a13fb | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5026611c-93e7-8f90-e063-6394a90a7baa | 2026-04-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0 | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | COSTCO WHOLESALE CORPORATION | 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 4f963491-e1f0-494d-acb6-5f4d2b267d4a | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | f4b01827-7444-3bfc-e053-2a95a90aebed | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH, | cfd43b8f-8064-6b88-e053-2a95a90a329e | 2026-04-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1119541 | dextromethorphan HBr 5 MG / guaiFENesin 75 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | 1 |
| 1119541 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | 1 |
| 1119541 | dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | f85d8586-423f-48a3-9bb2-bbc5984c7cd3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63102-130-16 | 63102013016 | 473 mL in 1 BOTTLE, PLASTIC (63102-130-16) | 473 ml | 2026-02-12 | No | No | Current |