NDC 58805-002 Acetaminophen, Dextromethorphan, Phenylephrine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
58805-002
Proprietary Name:
Acetaminophen, Dextromethorphan, Phenylephrine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Agile Pharmachem
Labeler Code:
58805
Start Marketing Date: [9]
05-01-2014
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
512
Score:
1

Product Packages

NDC Code 58805-002-08

Package Description: 8 CARTON in 1 BLISTER PACK / 180 CAPSULE, LIQUID FILLED in 1 CARTON

NDC Code 58805-002-14

Package Description: 7680 CARTON in 1 BLISTER PACK / 1 CAPSULE, LIQUID FILLED in 1 CARTON

Product Details

What is NDC 58805-002?

The NDC code 58805-002 is assigned by the FDA to the product Acetaminophen, Dextromethorphan, Phenylephrine which is product labeled by Agile Pharmachem. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 58805-002-08 8 carton in 1 blister pack / 180 capsule, liquid filled in 1 carton, 58805-002-14 7680 carton in 1 blister pack / 1 capsule, liquid filled in 1 carton. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Acetaminophen, Dextromethorphan, Phenylephrine?

This product is used as Pain relieverCough SuppressantNasal decongestant. Pain reliever, cough suppressant and Nasal decongestant

Which are Acetaminophen, Dextromethorphan, Phenylephrine UNII Codes?

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

Which are Acetaminophen, Dextromethorphan, Phenylephrine Inactive Ingredients 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:

What is the NDC to RxNorm Crosswalk for Acetaminophen, Dextromethorphan, Phenylephrine?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".