m-dryl

Generic: diphenhydramine hydrochloride

Labeler: method pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name m-dryl
Generic Name diphenhydramine hydrochloride
Labeler method pharmaceuticals, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Method Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 58657-528
Product ID 58657-528_41b56261-e688-a46d-e063-6394a90a9246
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-08-01

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 58657528
Hyphenated Format 58657-528

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 m-dryl (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (58657-528-04)
  • 473 mL in 1 BOTTLE (58657-528-16)
source: ndc

Packages (2)

58657-528-04 120 mL in 1 BOTTLE (58657-528-04) 58657-528-16 473 mL in 1 BOTTLE (58657-528-16)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

M-Dryl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41b56261-e688-a46d-e063-6394a90a9246", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["5a60c923-8bb7-427f-9636-08ed5474f71b"], "manufacturer_name": ["Method Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (58657-528-04)", "package_ndc": "58657-528-04", "marketing_start_date": "20190801"}, {"sample": false, "description": "473 mL in 1 BOTTLE (58657-528-16)", "package_ndc": "58657-528-16", "marketing_start_date": "20190801"}], "brand_name": "M-Dryl", "product_id": "58657-528_41b56261-e688-a46d-e063-6394a90a9246", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58657-528", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Method Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "M-Dryl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190801", "listing_expiration_date": "20261231"}