diphenhydramine oral liquid

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name diphenhydramine oral liquid
Generic Name diphenhydramine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-305
Product ID 57237-305_952598aa-cb50-400d-85da-e8acab206e5a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M009.50
Listing Expiration 2026-12-31
Marketing Start 2022-12-19

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 57237305
Hyphenated Format 57237-305

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 diphenhydramine oral liquid (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M009.50 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (57237-305-12)
  • 473 mL in 1 BOTTLE (57237-305-16)
source: ndc

Packages (2)

57237-305-12 118 mL in 1 BOTTLE (57237-305-12) 57237-305-16 473 mL in 1 BOTTLE (57237-305-16)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine Oral Liquid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "952598aa-cb50-400d-85da-e8acab206e5a", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["d8462e6f-a9fb-4701-97e2-d81a47f3e196"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (57237-305-12)", "package_ndc": "57237-305-12", "marketing_start_date": "20221219"}, {"sample": false, "description": "473 mL in 1 BOTTLE (57237-305-16)", "package_ndc": "57237-305-16", "marketing_start_date": "20221219"}], "brand_name": "Diphenhydramine Oral Liquid", "product_id": "57237-305_952598aa-cb50-400d-85da-e8acab206e5a", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57237-305", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Oral Liquid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M009.50", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221219", "listing_expiration_date": "20261231"}