sanatos daytime

Generic: acetaminophen, dextromethorphan, phenylephrine

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

Drug Facts

Product Profile

Brand Name sanatos daytime
Generic Name acetaminophen, dextromethorphan, phenylephrine
Labeler pharmadel llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-508
Product ID 55758-508_3bddcd5a-7777-49ff-e063-6294a90a5dd1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-08-08

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55758508
Hyphenated Format 55758-508

Supplemental Identifiers

RxCUI
1086997
UNII
362O9ITL9D 9D2RTI9KYH 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 daytime (source: ndc)
Generic Name acetaminophen, dextromethorphan, phenylephrine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (55758-508-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

55758-508-08 1 BLISTER PACK in 1 CARTON (55758-508-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Sanatos Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3bddcd5a-7777-49ff-e063-6294a90a5dd1", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["3bddcd5a-7776-49ff-e063-6294a90a5dd1"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55758-508-08)  / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "55758-508-08", "marketing_start_date": "20250808"}], "brand_name": "Sanatos Daytime", "product_id": "55758-508_3bddcd5a-7777-49ff-e063-6294a90a5dd1", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "55758-508", "generic_name": "Acetaminophen, Dextromethorphan, Phenylephrine", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sanatos", "brand_name_suffix": "Daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250808", "listing_expiration_date": "20261231"}