childrens allergy

Generic: diphenhydramine hydrochloride

Labeler: aptapharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens allergy
Generic Name diphenhydramine hydrochloride
Labeler aptapharma inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
AptaPharma Inc.

Identifiers & Regulatory

Product NDC 76281-505
Product ID 76281-505_46e2e387-098c-8f8f-e063-6294a90add68
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-09-30

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 76281505
Hyphenated Format 76281-505

Supplemental Identifiers

RxCUI
1049906
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 (76281-505-24)
source: ndc

Packages (1)

76281-505-24 118 mL in 1 BOTTLE (76281-505-24)

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": "46e2e387-098c-8f8f-e063-6294a90add68", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["b2cef61f-ab54-4a20-a7f7-6d3da4754e8b"], "manufacturer_name": ["AptaPharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (76281-505-24)", "package_ndc": "76281-505-24", "marketing_start_date": "20200930"}], "brand_name": "Childrens Allergy", "product_id": "76281-505_46e2e387-098c-8f8f-e063-6294a90add68", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76281-505", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "AptaPharma Inc.", "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": "20200930", "listing_expiration_date": "20261231"}