diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl
Generic Name diphenhydramine hcl
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6985
Product ID 0904-6985_7e4a9b77-587a-427c-907f-39f7d54ea5d6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2019-08-27
Marketing End 2027-05-31

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 09046985
Hyphenated Format 0904-6985

Supplemental Identifiers

RxCUI
1049906
UPC
0309046985167
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 hcl (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (0904-6985-16)
  • 118 mL in 1 BOTTLE, PLASTIC (0904-6985-20)
source: ndc

Packages (2)

0904-6985-16 473 mL in 1 BOTTLE, PLASTIC (0904-6985-16) 0904-6985-20 118 mL in 1 BOTTLE, PLASTIC (0904-6985-20)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7e4a9b77-587a-427c-907f-39f7d54ea5d6", "openfda": {"upc": ["0309046985167"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["93753885-6add-462c-9df8-b0a1b9ce36c9"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0904-6985-16)", "package_ndc": "0904-6985-16", "marketing_end_date": "20270430", "marketing_start_date": "20190827"}, {"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (0904-6985-20)", "package_ndc": "0904-6985-20", "marketing_end_date": "20270531", "marketing_start_date": "20190827"}], "brand_name": "Diphenhydramine HCl", "product_id": "0904-6985_7e4a9b77-587a-427c-907f-39f7d54ea5d6", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-6985", "generic_name": "Diphenhydramine HCl", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270531", "marketing_start_date": "20190827"}