dimetane

Generic: diphenhydramine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dimetane
Generic Name diphenhydramine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine 50 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-368
Product ID 57237-368_958e9dae-4d1c-40fc-b84d-20f2ed6996c0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2026-01-27

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 57237368
Hyphenated Format 57237-368

Supplemental Identifiers

RxCUI
1020477 1049909
UPC
0357237368992
UNII
8GTS82S83M TC2D6JAD40
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 dimetane (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-01)
  • 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-99)
source: ndc

Packages (2)

57237-368-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-01) 57237-368-99 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-99)

Ingredients (1)

diphenhydramine (50 mg/1)

Linked Drug Pages (1)

Dimetane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "958e9dae-4d1c-40fc-b84d-20f2ed6996c0", "openfda": {"nui": ["N0000000190", "N0000175587"], "upc": ["0357237368992"], "unii": ["8GTS82S83M", "TC2D6JAD40"], "rxcui": ["1020477", "1049909"], "spl_set_id": ["484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-01)", "package_ndc": "57237-368-01", "marketing_start_date": "20260127"}, {"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-99)", "package_ndc": "57237-368-99", "marketing_start_date": "20260127"}], "brand_name": "Dimetane", "product_id": "57237-368_958e9dae-4d1c-40fc-b84d-20f2ed6996c0", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57237-368", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimetane", "active_ingredients": [{"name": "DIPHENHYDRAMINE", "strength": "50 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260127", "listing_expiration_date": "20271231"}