Acetaminophen Diphenhydramine Hcl
NDC 69842-308

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69842-308?
  5. Acetaminophen Diphenhydramine Hcl Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Acetaminophen Diphenhydramine Hcl is a OTC MONOGRAPH NOT FINAL-approved product labeled by Cvs Pharmacy, Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a gray product. This product entry covers the primary NDC 69842-308 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
69842-308
Proprietary Name:
Acetaminophen Diphenhydramine Hcl
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Cvs Pharmacy, Inc
Labeler Code:
69842
Product Label ID:
76f3e037-47de-28b5-e053-2991aa0a2859
FDA Application Number: [6]
part343
Marketing Category: [8]
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.

Marketing Timeline

Start Marketing Date: [9]
01-29-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GRAY (C48324 - ENCAPSULATED GRAY COLOR TABLETS WITH ONE RED OPAQUE AND ONE BLUE-GRAY OPAQUE HARD GELATIN SHELLS)
GRAY (C48324 - ENCAPSULATED GRAY COLOR TABLETS WITH DARK BLUE OPAQUE AND LIGHT BLUE OPAQUE HARD GELATIN SHELLS)
Shape:
OVAL (C48345)
Size(s):
20 MM
Imprint(s):
G1;G3
Score:
1

Code Structure Chart

Product Details

What is NDC 69842-308?

The NDC code 69842-308 is assigned by the FDA to the product Acetaminophen Diphenhydramine Hcl. This pharmaceutical product is labeled by Cvs Pharmacy, Inc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 69842-308-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

■ do not take more than directedadults and children 12 years and over■ take 2 gelcaps every 6 hours while symptoms last■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor■ do not take more than 10 days unless directed by a doctorchildren under 12 years■ ask a doctor ■ do not take more than directed (see overdose warning)adults and children 12 years and over■ take 2 gelcaps at bedtime■ do not take more than 2 gelcaps of this product in 24 hourschildren under 12 years■ do not use

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
What is the Marketing Category? 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".