allergy relief childrens

Generic: diphenhydramine hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief childrens
Generic Name diphenhydramine hcl
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7533
Product ID 0904-7533_3648f1ee-b2d4-41d9-ac39-c8ec482a6e92
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-03-07

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 09047533
Hyphenated Format 0904-7533

Supplemental Identifiers

RxCUI
1049906
UPC
0309047533152
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 allergy relief childrens (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
  • 473 mL in 1 BOTTLE, PLASTIC (0904-7533-15)
  • 1 BOTTLE, PLASTIC in 1 CARTON (0904-7533-20) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

0904-7533-15 473 mL in 1 BOTTLE, PLASTIC (0904-7533-15) 0904-7533-20 1 BOTTLE, PLASTIC in 1 CARTON (0904-7533-20) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Allergy Relief Childrens ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3648f1ee-b2d4-41d9-ac39-c8ec482a6e92", "openfda": {"upc": ["0309047533152"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["3a976e90-c6af-4414-984e-9987158c9e98"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0904-7533-15)", "package_ndc": "0904-7533-15", "marketing_start_date": "20250307"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0904-7533-20)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0904-7533-20", "marketing_start_date": "20250307"}], "brand_name": "Allergy Relief Childrens", "product_id": "0904-7533_3648f1ee-b2d4-41d9-ac39-c8ec482a6e92", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-7533", "generic_name": "Diphenhydramine HCl", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy Relief", "brand_name_suffix": "Childrens", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250307", "listing_expiration_date": "20271231"}