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NDC 58657-0528-04 M-Dryl 12.5 mg/5mL Details
M-Dryl 12.5 mg/5mL
M-Dryl is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Method Pharmaceuticals, LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 58657-0528-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 58657-0528 |
|---|---|
| Product ID | 58657-528_0c5bb478-7c61-4a3d-e063-6294a90a1000 |
| Associated GPIs | 41200030100920 |
| GCN Sequence Number | 016675 |
| GCN Sequence Number Description | diphenhydramine HCl LIQUID 12.5MG/5ML ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 48831 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | M-Dryl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 12.5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Method Pharmaceuticals, LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58657-0528-04 (58657052804)
| NDC Package Code | 58657-528-04 |
|---|---|
| Billing NDC | 58657052804 |
| Package | 120 mL in 1 BOTTLE (58657-528-04) |
| Marketing Start Date | 2019-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |