NDC 36800-504

Severe Cold PE

Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride

Severe Cold PE is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Topcare. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 36800-504_7e318eb2-2b95-18e4-e053-2a91aa0adf1f
• NDC: 36800-504
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold PE
• Generic Name: Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: TopCare
• Substance Name: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 36800-504-03

2 BLISTER PACK in 1 CARTON (36800-504-03) > 12 TABLET, COATED in 1 BLISTER PACK

• Marketing Start Date: 2013-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-504-03 [36800050403]

Severe Cold PE TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-07-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 963bbd2c-3ea1-4699-9caa-fbc7d95a4e53
• Manufacturer:
  • TopCare
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1233575
• UPC Code:
  • 0036800386143

NDC Crossover Matching brand name "Severe Cold PE" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
15127-974	Severe Cold PE	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
36800-504	Severe Cold PE	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
57344-124	Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
57344-125	Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
57344-127	Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
57344-155	Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
57344-156	Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
57344-126	Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
15127-973	Allergy and Cold PE	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
46122-053	Allergy Plus Severe Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-501	Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
46122-052	Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
46122-405	Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
61941-0301	Cold-EEZE	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
61941-0401	Cold-EEZE	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
63824-110	Delsym	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
63824-211	Delsym	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
30142-113	Kroger NiteTime Flu plus Severe Cold and Cough	Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
51672-2113	Nighttime	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
11822-2113	Rite Aid Nighttime Severe Cold and Cough Relief	Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
55758-009	SanaTos Severe Cold and Cough Nighttime	Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
36800-500	Severe Allergy Plus Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
50804-473	Severe Allergy Relief Plus Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
41190-113	ShopRite Nighttime Flu Plus Severe Cold and Cough	Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
11673-113	up and up	Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
37000-926	VIcks Flu Therapy	acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride
58933-926	VIcks Flu Therapy	acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride