Search by Drug Name or NDC
NDC 70000-0467-01 leader sleep aid 25 mg/1 Details
leader sleep aid 25 mg/1
leader sleep aid is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0467-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
NDC | 70000-0467 |
---|---|
Product ID | 70000-0467_c03e7e53-70fb-4baa-a4ec-5865acb7a6ac |
Associated GPIs | |
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 | leader sleep aid |
Proprietary Name Suffix | n/a |
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 | Cardinal Health 110, LLC. dba Leader |
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
Package Images

NDC 70000-0467-01 (70000046701)
NDC Package Code | 70000-0467-1 |
---|---|
Billing NDC | 70000046701 |
Package | 12 BLISTER PACK in 1 CARTON (70000-0467-1) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
Marketing Start Date | 2019-02-25 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.06375 |
Pricing Unit | EA |
Effective Date | 2022-06-22 |
NDC Description | SLEEP AID 25 MG CAPLET |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2022-07-06 |
Standard Product Labeling (SPL)/Prescribing Information SPL 66d16f50-1fcc-447c-be71-f9eaa3dc99a1 Details
Warnings
Do not use
- •
- in children under 12 years of age
- •
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
- •
- glaucoma
When using this product
- •
- avoid alcoholic drinks
- •
- drowsiness may occur
- •
- do not drive a motor vehicle or operate machinery
Directions
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
LEADER SLEEP AID
diphenhydramine hydrochloride tablet, film coated |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
Labeler - Cardinal Health 110, LLC. dba Leader (063997360) |