68788-9687 NDC - DIPHENHYDRAMINE HCL

Drug Information

Product NDC: 68788-9687
Proprietary Name: Diphenhydramine HCL
Non Proprietary Name: Diphenhydramine HCL
Active Ingredient(s): 25 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Pharmacy Class(es): Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Preferred Pharmaceuticals, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:	341
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	3/27/2013

Package Information

No.	Package Code	Package Description	Billing Unit
1	68788-9687-0	10 CAPSULE in 1 BOTTLE, PLASTIC (68788-9687-0)
2	68788-9687-1	15 CAPSULE in 1 BOTTLE, PLASTIC (68788-9687-1)
3	68788-9687-3	30 CAPSULE in 1 BOTTLE, PLASTIC (68788-9687-3)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	68788-9687	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAME	HUMAN OTC DRUG	This is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAME	Diphenhydramine HCL	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
NON PROPRIETARY NAME	Diphenhydramine HCL	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.
DOSAGE FORM NAME	CAPSULE	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ROUTE NAME	ORAL	Name of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE	3/27/2013	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	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.
APPLICATION NUMBER	341	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Preferred Pharmaceuticals, Inc.	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
SUBSTANCE NAME	DIPHENHYDRAMINE HYDROCHLORIDE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	25
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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This page was last updated on: 12/19/2025

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