70934-497 NDC - DIPHENHYDRAMINE HCL ()

Drug Information

Product NDC: 70934-497
Proprietary Name: Diphenhydramine HCL
Non Proprietary Name:
Active Ingredient(s):
Administration Route(s):
Dosage Form(s):

Labeler Information

Field Name	Field Value
Labeler Name:	Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Product Type:
FDA Application Number:	part341
Marketing Category:	OTC MONOGRAPH FINAL
Start Marketing Date:	1/21/2020
End Marketing Date:	11/30/2022

Package Information

No.	Package Code	Package Description	Billing Unit
1	70934-497-20	20 CAPSULE in 1 BOTTLE, PLASTIC (70934-497-20)
2	70934-497-30	30 CAPSULE in 1 BOTTLE, PLASTIC (70934-497-30)
3	70934-497-60	60 CAPSULE in 1 BOTTLE, PLASTIC (70934-497-60)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	70934-497	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAME	Diphenhydramine HCL	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
START MARKETING DATE	1/21/2020	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
END MARKETING DATE	11/30/2022	The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAME	OTC MONOGRAPH FINAL	The translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBER	part341	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

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This page was last updated on: 12/6/2025

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