childrens allergy

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name childrens allergy
Generic Name diphenhydramine hydrochloride
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0292
Product ID 49580-0292_79fc4013-85e6-4276-bc54-26ac0951bd0e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-03-31

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 495800292
Hyphenated Format 49580-0292

Supplemental Identifiers

RxCUI
1049906
UPC
0349580292406
UNII
TC2D6JAD40

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 allergy (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (49580-0292-2)
  • 1 BOTTLE, PLASTIC in 1 BOX (49580-0292-4) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

49580-0292-2 118 mL in 1 BOTTLE, PLASTIC (49580-0292-2) 49580-0292-4 1 BOTTLE, PLASTIC in 1 BOX (49580-0292-4) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Childrens Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79fc4013-85e6-4276-bc54-26ac0951bd0e", "openfda": {"upc": ["0349580292406"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["8559be55-8b00-4353-8e26-b5dff2ada806"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (49580-0292-2)", "package_ndc": "49580-0292-2", "marketing_start_date": "20150331"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (49580-0292-4)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49580-0292-4", "marketing_start_date": "20150331"}], "brand_name": "Childrens Allergy", "product_id": "49580-0292_79fc4013-85e6-4276-bc54-26ac0951bd0e", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49580-0292", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Allergy", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150331", "listing_expiration_date": "20261231"}