childrens allergy

Generic: diphenhydramine hcl

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

Drug Facts

Product Profile

Brand Name childrens allergy
Generic Name diphenhydramine hcl
Labeler genexa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Genexa Inc.

Identifiers & Regulatory

Product NDC 69676-0074
Product ID 69676-0074_2ea022ca-e2ee-3856-e063-6294a90a484f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-04-26

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 696760074
Hyphenated Format 69676-0074

Supplemental Identifiers

RxCUI
1049906
UPC
0850015736001
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 hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (69676-0074-9) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

69676-0074-9 1 BOTTLE, PLASTIC in 1 CARTON (69676-0074-9) / 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": "2ea022ca-e2ee-3856-e063-6294a90a484f", "openfda": {"upc": ["0850015736001"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["e880b8d7-61c3-41cc-e053-2995a90aaaeb"], "manufacturer_name": ["Genexa Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69676-0074-9)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69676-0074-9", "marketing_start_date": "20220426"}], "brand_name": "Childrens Allergy", "product_id": "69676-0074_2ea022ca-e2ee-3856-e063-6294a90a484f", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69676-0074", "generic_name": "Diphenhydramine HCl", "labeler_name": "Genexa 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": "20220426", "listing_expiration_date": "20261231"}