nighttime severe cold and cough

Generic: acetaminophen, diphenhydramine, phenylephrine

Labeler: raritan pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime severe cold and cough
Generic Name acetaminophen, diphenhydramine, phenylephrine
Labeler raritan pharmaceuticals inc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
RARITAN PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 68163-541
Product ID 68163-541_3fc356a6-ea68-ed5b-e063-6394a90a02c6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-03-22

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 68163541
Hyphenated Format 68163-541

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 nighttime severe cold and cough (source: ndc)
Generic Name acetaminophen, diphenhydramine, phenylephrine (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 PACKET in 1 CARTON (68163-541-06) / 1 POWDER, FOR SOLUTION in 1 PACKET
source: ndc

Packages (1)

68163-541-06 6 PACKET in 1 CARTON (68163-541-06) / 1 POWDER, FOR SOLUTION in 1 PACKET

Ingredients (3)

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

Linked Drug Pages (1)

Nighttime Severe Cold and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fc356a6-ea68-ed5b-e063-6394a90a02c6", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1659960"], "spl_set_id": ["9819155b-2713-42be-867e-16605e7643d0"], "manufacturer_name": ["RARITAN PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 CARTON (68163-541-06)  / 1 POWDER, FOR SOLUTION in 1 PACKET", "package_ndc": "68163-541-06", "marketing_start_date": "20190322"}], "brand_name": "Nighttime Severe Cold and Cough", "product_id": "68163-541_3fc356a6-ea68-ed5b-e063-6394a90a02c6", "dosage_form": "POWDER, 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": "68163-541", "generic_name": "ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE", "labeler_name": "RARITAN PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Severe Cold and Cough", "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": "20190322", "listing_expiration_date": "20261231"}