diphenhydramine hcl 12.5 mg per 5 ml

Generic: diphenhydramine hcl 12.5 mg per 5 ml

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

Drug Facts

Product Profile

Brand Name diphenhydramine hcl 12.5 mg per 5 ml
Generic Name diphenhydramine hcl 12.5 mg per 5 ml
Labeler aarna usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine 12.5 mg/5mL

Manufacturer
AARNA USA INC.

Identifiers & Regulatory

Product NDC 82568-0016
Product ID 82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 825680016
Hyphenated Format 82568-0016

Supplemental Identifiers

RxCUI
1049906
UNII
8GTS82S83M
NUI
N0000000190 N0000175587

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 diphenhydramine hcl 12.5 mg per 5 ml (source: ndc)
Generic Name diphenhydramine hcl 12.5 mg per 5 ml (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 (82568-0016-4)
  • 473 mL in 1 BOTTLE (82568-0016-6)
  • 236 mL in 1 BOTTLE (82568-0016-8)
source: ndc

Packages (3)

82568-0016-4 118 mL in 1 BOTTLE (82568-0016-4) 82568-0016-6 473 mL in 1 BOTTLE (82568-0016-6) 82568-0016-8 236 mL in 1 BOTTLE (82568-0016-8)

Ingredients (1)

diphenhydramine (12.5 mg/5mL)

Linked Drug Pages (1)

DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3404aa22-166f-5501-e063-6394a90a1e7a", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["8GTS82S83M"], "rxcui": ["1049906"], "spl_set_id": ["32c26835-f54e-d7e5-e063-6294a90ae1c0"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["AARNA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (82568-0016-4)", "package_ndc": "82568-0016-4", "marketing_start_date": "20250414"}, {"sample": false, "description": "473 mL in 1 BOTTLE (82568-0016-6)", "package_ndc": "82568-0016-6", "marketing_start_date": "20250414"}, {"sample": false, "description": "236 mL in 1 BOTTLE (82568-0016-8)", "package_ndc": "82568-0016-8", "marketing_start_date": "20250414"}], "brand_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML", "product_id": "82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "82568-0016", "generic_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML", "labeler_name": "AARNA USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML", "active_ingredients": [{"name": "DIPHENHYDRAMINE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}