childrens triacting nighttime cold and cough readyincase

Generic: diphenhydramine hcl, phenylephrine hcl

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens triacting nighttime cold and cough readyincase
Generic Name diphenhydramine hcl, phenylephrine hcl
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 6.25 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0379
Product ID 49580-0379_f4d797cd-2bcd-41e6-b683-93d70e31da64
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-11-30

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 495800379
Hyphenated Format 49580-0379

Supplemental Identifiers

RxCUI
1236048
UPC
0349580379404
UNII
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 childrens triacting nighttime cold and cough readyincase (source: ndc)
Generic Name diphenhydramine hcl, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (49580-0379-4) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

49580-0379-4 1 BOTTLE, PLASTIC in 1 BOX (49580-0379-4) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

diphenhydramine hydrochloride (6.25 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Childrens Triacting Nighttime Cold and Cough ReadyInCase ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f4d797cd-2bcd-41e6-b683-93d70e31da64", "openfda": {"upc": ["0349580379404"], "unii": ["TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1236048"], "spl_set_id": ["61980e57-5b94-4ae2-8e08-848749e4abcd"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (49580-0379-4)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49580-0379-4", "marketing_start_date": "20141130"}], "brand_name": "Childrens Triacting Nighttime Cold and Cough ReadyInCase", "product_id": "49580-0379_f4d797cd-2bcd-41e6-b683-93d70e31da64", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "49580-0379", "generic_name": "Diphenhydramine HCl, Phenylephrine HCl", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Triacting Nighttime", "brand_name_suffix": "Cold and Cough ReadyInCase", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141130", "listing_expiration_date": "20261231"}