ACTICON PEDIATRIC
- Product NDC
- 63102-109
- 11-digit product format
- 631020109
- Labeler code
- 63102
- Product ID
- 63102-109_72bd27ec-46f9-460c-a600-da5eb8dcd3b0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ACTIPHARMA, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-17
- Substance
- DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 1; 30 mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACTICON PEDIATRIC
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXBROMPHENIRAMINE MALEATE | 1 mg/5mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | BPA9UT29BS, 6V9V2RYJ8N |
| Rxcui | 1299143 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 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 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63102-109-16 | ACTICON PEDIATRIC | 473 mL in 1 BOTTLE | SOLUTION | 473 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63102-109-16 | ML - Milliliter | 63102-109 | 186a487a-f1b1-440d-a1d5-6aa3d900dabe | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1299143 | dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution | PSN | 3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23 | 1 |
| 1299143 | dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution | SCD | 3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23 | 1 |
| 1299143 | dexbrompheniramine maleate 1 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution | SY | 3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63102-109-16 | 63102010916 | 473 mL in 1 BOTTLE (63102-109-16) | 473 ml | 2025-07-17 | No | No | Current |