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NDC 36800-0431-78 topcare sleep aid 25 mg/1 Details
topcare sleep aid 25 mg/1
topcare sleep aid is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates 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: 36800-0431-78Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 36800-0431 |
|---|---|
| Product ID | 36800-431_794ac57b-5dfb-4414-a01b-084f3676c90c |
| Associated GPIs | 60300020100305 |
| GCN Sequence Number | 003705 |
| GCN Sequence Number Description | diphenhydramine HCl TABLET 25 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 27481 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | topcare sleep aid |
| Proprietary Name Suffix | nighttime |
| Non-Proprietary Name | Diphenhydramine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part338 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0431-78 (36800043178)
| NDC Package Code | 36800-431-78 |
|---|---|
| Billing NDC | 36800043178 |
| Package | 1 BOTTLE in 1 CARTON (36800-431-78) / 100 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2017-09-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |