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 |
|---|---|---|---|---|---|---|
| DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c55543-e05e-2f7c-e063-6394a90a4534 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 38049d29-f47e-9478-e063-6294a90aa2a4 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3804a271-9a11-848d-e063-6394a90af87d | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805ef07-247d-0df7-e063-6394a90ac45b | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drop Black Cherry Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805f8f5-562f-0ba8-e063-6394a90ac9d9 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Army & Air Force Exchange Service | 3805f90e-bd89-128d-e063-6394a90afa01 | 2025-06-20 | Warnings | M012 |
| TARGET Multi Symptom Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | TARGET CORPORATION | aebe3c15-53ef-46ea-af39-8c9b8114595f | 2025-06-20 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | be95332d-a2e0-42e8-bfb3-8850d74990ff | 2025-06-19 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | 37e939c6-064b-3548-e063-6294a90a337d | 2025-06-19 | Warnings | M012 |
| Capron DM | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | cf778c5f-475e-4a86-a87c-2be1e665f5a5 | 2025-06-18 | Warnings | M012 |
| Cough Out | GUAIFENESIN | Efficient Laboratories Inc. | fe4c3921-8d30-4cd6-ba90-9211b362a38a | 2025-06-18 | Warnings | M012 |
| Guaifenesin STRAWBERRY-BANANA FLAVOR | GUAIFENESIN | Innovida Pharmaeutique Corporation | 1006906e-d6d7-4f49-92bf-3cb2d2cdbb16 | 2025-06-18 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool | ACETAMINOPHEN AND GUAIFENESIN | RB Health (US) LLC | 37de813a-54b7-672a-e063-6294a90a374e | 2025-06-18 | Warnings | M012 |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a1aeb41-a8fa-4116-8068-e11acd608e58 | 2025-06-18 | Warnings | M012 |
| NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c768f5-dabd-22d0-e063-6394a90af9e5 | 2025-06-17 | Warnings | M012 |
| DISCOUNT DRUG MART Childrens Allergy Chewable | DIPHENHYDRAMINE HCL | DISCOUNT DRUG MART | 51de95da-e8e8-48f0-9fa4-6191aa4a247b | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | 5f4af8e8-8550-45c7-a199-694efac9e7be | 2025-06-16 | Warnings | M012 |
| Halls Honey Lemon | MENTHOL | Mondelez Global LLC | 25eaae85-d516-40da-a472-70736ea2b75d | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | bad89968-22a7-4287-a57c-9e6206e574fe | 2025-06-16 | Warnings | M012 |
| Herbal Throat Drops | LEMON MINT HERBAL | Meijer, Inc. | 37dd58ad-95d1-568c-e063-6394a90a9433 | 2025-06-16 | 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 |