NDC 50580-566

Tylenol Cold Plus Head Congestion Severe

Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride

Tylenol Cold Plus Head Congestion Severe is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 50580-566_60b3ac2f-4614-4a71-8b3a-419ecd0ad89f
• NDC: 50580-566
• Product Type: Human Otc Drug
• Proprietary Name: Tylenol Cold Plus Head Congestion Severe
• Generic Name: Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-15
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• 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 50580-566-25

2 BLISTER PACK in 1 CARTON (50580-566-25) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2013-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-566-25 [50580056625]

Tylenol Cold Plus Head Congestion Severe TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-15

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: ce43e5c2-fe96-4462-882c-d7479318b33d
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1243679

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

NDC	Brand Name	Generic Name
50580-566	Tylenol Cold Plus Head Congestion Severe	Tylenol Cold Plus Head Congestion Severe
36800-575	Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
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