NDC 55315-527

Sinus Congestion and Pain Non Drowsy

Acetaminophen, Guaifenesin And Phenylephrine Hcl

Sinus Congestion and Pain Non Drowsy is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 55315-527_2e8002d9-75a7-40b3-bd81-66fb98d5a5bc
• NDC: 55315-527
• Product Type: Human Otc Drug
• Proprietary Name: Sinus Congestion and Pain Non Drowsy
• Generic Name: Acetaminophen, Guaifenesin And Phenylephrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-08-06
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: FRED'S, INC.
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55315-527-08

2 BLISTER PACK in 1 CARTON (55315-527-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2005-08-06
• Marketing End Date: 2022-04-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55315-527-08 [55315052708]

Sinus Congestion and Pain Non Drowsy TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-08-06

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: a9a36ef0-70b0-4934-94c2-399a03269823
• Manufacturer:
  • FRED'S, INC.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1243679
• UPC Code:
  • 0084579102198

NDC Crossover Matching brand name "Sinus Congestion and Pain Non Drowsy" or generic name "Acetaminophen, Guaifenesin And Phenylephrine Hcl"

NDC	Brand Name	Generic Name
67060-106	COLD TABS II	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL
68210-4164	Non-Drowsy Daytime Severe Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
0363-0412	Non-Drowsy Wal-Phed PE Triple Relief	Acetaminophen, Guaifenesin and Phenylephrine HCl
0363-5270	Severe Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
63941-527	Severe Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
33992-0527	Severe Sinus Congestion and Pain Daytime	Acetaminophen, Guaifenesin and Phenylephrine HCl
15127-963	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
49035-527	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
55301-527	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
55315-527	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
55910-527	Sinus Congestion And Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
11822-0527	Sinus Congestion and Pain Relief	Acetaminophen, Guaifenesin and Phenylephrine HCl
0363-5279	Sinus PE Pressure, Pain and Mucus	Acetaminophen, Guaifenesin and Phenylephrine HCl