childrens delsym cough plus cold night time

Generic: acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens delsym cough plus cold night time
Generic Name acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride
Labeler rb health (us) llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/10mL, diphenhydramine hydrochloride 12.5 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-212
Product ID 63824-212_29922ab4-e10f-c751-e063-6294a90ad44d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-03-18

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 63824212
Hyphenated Format 63824-212

Supplemental Identifiers

RxCUI
1375932
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 childrens delsym cough plus cold night time (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/10mL
  • 12.5 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63824-212-64) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

63824-212-64 1 BOTTLE in 1 CARTON (63824-212-64) / 118 mL in 1 BOTTLE

Ingredients (3)

acetaminophen (325 mg/10mL) diphenhydramine hydrochloride (12.5 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Childrens Delsym Cough Plus Cold Night Time ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "29922ab4-e10f-c751-e063-6294a90ad44d", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1375932"], "spl_set_id": ["00689aa5-ed39-4c9a-92b8-105d2c0e2e15"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63824-212-64)  / 118 mL in 1 BOTTLE", "package_ndc": "63824-212-64", "marketing_start_date": "20170609"}], "brand_name": "Childrens Delsym Cough Plus Cold Night Time", "product_id": "63824-212_29922ab4-e10f-c751-e063-6294a90ad44d", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "63824-212", "generic_name": "Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Delsym", "brand_name_suffix": "Cough Plus Cold Night Time", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130318", "listing_expiration_date": "20261231"}