childrens allergy relief

Generic: diphenhydramine hcl

Labeler: topco associates, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens allergy relief
Generic Name diphenhydramine hcl
Labeler topco associates, llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/1

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 36800-585
Product ID 36800-585_98a7feee-2825-4486-a985-a4d7f9260c8d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2009-03-20

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 36800585
Hyphenated Format 36800-585

Supplemental Identifiers

RxCUI
1049900
UPC
0036800414358
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 relief (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (36800-585-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "98a7feee-2825-4486-a985-a4d7f9260c8d", "openfda": {"upc": ["0036800414358"], "unii": ["TC2D6JAD40"], "rxcui": ["1049900"], "spl_set_id": ["bfcabe02-7961-4407-a748-8cd087731398"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (36800-585-44)  / 6 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "36800-585-44", "marketing_start_date": "20090320"}], "brand_name": "Childrens Allergy Relief", "product_id": "36800-585_98a7feee-2825-4486-a985-a4d7f9260c8d", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-585", "generic_name": "Diphenhydramine HCl", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Allergy Relief", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20090320", "listing_expiration_date": "20261231"}