NDC 55758-009

SanaTos Severe Cold and Cough Nighttime

Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride

SanaTos Severe Cold and Cough Nighttime is a Oral Granule, For Solution in the Human Otc Drug category. It is labeled and distributed by Pharmadel Llc. The primary component is Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride; Acetaminophen.

• Product ID: 55758-009_601e629c-d997-b73d-e053-2a91aa0ae9db
• NDC: 55758-009
• Product Type: Human Otc Drug
• Proprietary Name: SanaTos Severe Cold and Cough Nighttime
• Generic Name: Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
• Dosage Form: Granule, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-02-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Pharmadel LLC
• Substance Name: DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
• Active Ingredient Strength: 25 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55758-009-01

1 GRANULE, FOR SOLUTION in 1 POUCH (55758-009-01)

• Marketing Start Date: 2014-02-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55758-009-01 [55758000901]

SanaTos Severe Cold and Cough Nighttime GRANULE, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-20

NDC 55758-009-18 [55758000918]

SanaTos Severe Cold and Cough Nighttime GRANULE, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-03-01

NDC 55758-009-06 [55758000906]

SanaTos Severe Cold and Cough Nighttime GRANULE, FOR SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-20

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

OpenFDA Data

• SPL SET ID: b747cb49-e11b-4dca-90a3-2510b430880b
• Manufacturer:
  • Pharmadel LLC
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1659960

NDC Crossover Matching brand name "SanaTos Severe Cold and Cough Nighttime" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
55758-009	SanaTos Severe Cold and Cough Nighttime	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
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
15127-974	Severe Cold PE	Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
36800-504	Severe Cold PE	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