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NDC 00904-7237-61 Diphenhydramine Hydrochloride 25 mg/1 Details
Diphenhydramine Hydrochloride 25 mg/1
Diphenhydramine Hydrochloride is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.
Product Information
| NDC | 00904-7237 |
|---|---|
| Product ID | 0904-7237_dca04d80-e782-40b1-e053-2995a90a7010 |
| Associated GPIs | |
| GCN Sequence Number | 011582 |
| GCN Sequence Number Description | diphenhydramine HCl CAPSULE 25 MG ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 45971 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Diphenhydramine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-7237-61 (00904723761)
| NDC Package Code | 0904-7237-61 |
|---|---|
| Billing NDC | 00904723761 |
| Package | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7237-61) / 10 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2022-04-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04208 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DIPHENHYDRAMINE 25 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL dca04d80-e781-40b1-e053-2995a90a7010 Details
Uses
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
Directions
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268
Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.
To preserve quality and freshness, keep bottle tightly closed.
KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule |
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| Labeler - Major Pharmaceuticals (191427277) |
Revised: 4/2022
Document Id: dca04d80-e782-40b1-e053-2995a90a7010
Set id: dca04d80-e781-40b1-e053-2995a90a7010
Version: 1
Effective Time: 20220414