NDC 36800-575

Cold and Head Congestion Severe

Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride

Cold and Head Congestion Severe is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 36800-575_6b4eae21-d136-5ff1-e053-2991aa0a85e4
• NDC: 36800-575
• Product Type: Human Otc Drug
• Proprietary Name: Cold and Head Congestion Severe
• Generic Name: Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: TopCo Associates LLC
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 36800-575-02

2 BLISTER PACK in 1 CARTON (36800-575-02) > 12 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2017-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-575-02 [36800057502]

Cold and Head Congestion Severe TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-06-30

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: e07d880b-a12a-4e5e-94c0-bd36bcfe738c
• Manufacturer:
  • TopCo Associates LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1243679
• UPC Code:
  • 0036800420571

NDC Crossover Matching brand name "Cold and Head Congestion Severe" or generic name "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
36800-575	Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
50804-805	Cold and Head Congestion Severe	Cold and Head Congestion Severe
55910-927	Cold and Head Congestion Severe	Cold and Head Congestion Severe
68016-717	Cold and Head Congestion Severe	Cold and Head Congestion Severe
37808-775	Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-415	Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-275	COLD RELIEF SEVERE HEAD CONGESTION	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-793	Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-712	Head Congestion Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-573	head congestion plus mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-273	Mucus and Sinus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-267	mucus relief sinus severe congestion and pain	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-712	Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-367	Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-512	Pressure and Pain PE Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-773	Pressure Plus Pain PE Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-788	PRESSURE plus PAIN plus MUCUS	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-789	SEVERE COLD HEAD CONGESTION	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-505	Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49348-117	Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-229	Sinus Relief Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-219	sinus severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-412	Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-119	Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
50405-009	SohMed Sinus	Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
50580-447	SUDAFED PE Head Congestion Plus Mucus	acetaminophen, guaifenesin, and phenylephrine hydrochloride
50066-305	Tukol Max Action Sinus Liquid	Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
50580-507	Tylenol Sinus Severe	Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride