diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7237
Product ID 0904-7237_4b433ad6-a0bd-3f85-e063-6394a90a0785
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2022-04-14
Marketing End 2028-04-30

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 09047237
Hyphenated Format 0904-7237

Supplemental Identifiers

RxCUI
1049909
UPC
0309047237241
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 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
  • 2 BLISTER PACK in 1 CARTON (0904-7237-24) / 12 CAPSULE in 1 BLISTER PACK
  • 100 CAPSULE in 1 BOTTLE (0904-7237-60)
  • 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7237-61) / 10 CAPSULE in 1 BLISTER PACK
  • 1000 CAPSULE in 1 BOTTLE (0904-7237-80)
source: ndc

Packages (4)

0904-7237-24 2 BLISTER PACK in 1 CARTON (0904-7237-24) / 12 CAPSULE in 1 BLISTER PACK 0904-7237-60 100 CAPSULE in 1 BOTTLE (0904-7237-60) 0904-7237-61 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7237-61) / 10 CAPSULE in 1 BLISTER PACK 0904-7237-80 1000 CAPSULE in 1 BOTTLE (0904-7237-80)

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": "4b433ad6-a0bd-3f85-e063-6394a90a0785", "openfda": {"upc": ["0309047237241"], "unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["dca04d80-e781-40b1-e053-2995a90a7010"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0904-7237-24)  / 12 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7237-24", "marketing_end_date": "20280131", "marketing_start_date": "20220414"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0904-7237-60)", "package_ndc": "0904-7237-60", "marketing_end_date": "20280229", "marketing_start_date": "20220414"}, {"sample": false, "description": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7237-61)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7237-61", "marketing_end_date": "20280229", "marketing_start_date": "20220414"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (0904-7237-80)", "package_ndc": "0904-7237-80", "marketing_end_date": "20280430", "marketing_start_date": "20220414"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "0904-7237_4b433ad6-a0bd-3f85-e063-6394a90a0785", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-7237", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "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_end_date": "20280430", "marketing_start_date": "20220414"}