diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: precision dose, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler precision dose, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-018
Product ID 68094-018_315b150d-b34d-422c-b3c4-287dd908df8f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-07-15

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 68094018
Hyphenated Format 68094-018

Supplemental Identifiers

RxCUI
1049630
UNII
TC2D6JAD40

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

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (68094-018-61) / 10 TABLET in 1 BLISTER PACK (68094-018-59)
source: ndc

Packages (1)

68094-018-61 10 BLISTER PACK in 1 CARTON (68094-018-61) / 10 TABLET in 1 BLISTER PACK (68094-018-59)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "315b150d-b34d-422c-b3c4-287dd908df8f", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68094-018-61)  / 10 TABLET in 1 BLISTER PACK (68094-018-59)", "package_ndc": "68094-018-61", "marketing_start_date": "20190715"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "68094-018_315b150d-b34d-422c-b3c4-287dd908df8f", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68094-018", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190715", "listing_expiration_date": "20261231"}