sanatos severe cold relief nighttime

Generic: acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sanatos severe cold relief nighttime
Generic Name acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride
Labeler pharmadel llc
Dosage Form GRANULE, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, diphenhydramine hydrochloride 25 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-385
Product ID 55758-385_4873c00c-3edf-844a-e063-6394a90ac80d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2024-03-31

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55758385
Hyphenated Format 55758-385

Supplemental Identifiers

RxCUI
1659960
UNII
362O9ITL9D TC2D6JAD40 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sanatos severe cold relief nighttime (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 25 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06)
source: ndc

Packages (1)

55758-385-06 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06)

Ingredients (3)

acetaminophen (650 mg/1) diphenhydramine hydrochloride (25 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

SanaTos Severe Cold Relief Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4873c00c-3edf-844a-e063-6394a90ac80d", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1659960"], "spl_set_id": ["144aafcc-6ec2-a322-e063-6294a90afc27"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06)", "package_ndc": "55758-385-06", "marketing_start_date": "20240331"}], "brand_name": "SanaTos Severe Cold Relief Nighttime", "product_id": "55758-385_4873c00c-3edf-844a-e063-6394a90ac80d", "dosage_form": "GRANULE, FOR SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "55758-385", "generic_name": "Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SanaTos", "brand_name_suffix": "Severe Cold Relief Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240331", "listing_expiration_date": "20271231"}