diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl
Generic Name diphenhydramine hcl
Labeler nucare pharmaceuticals,inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3877
Product ID 68071-3877_47acca00-4497-1432-e063-6294a90a7bc8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2024-12-06

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 680713877
Hyphenated Format 68071-3877

Supplemental Identifiers

RxCUI
1049909
UPC
0368071387735
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 hcl (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (68071-3877-3)
  • 15 CAPSULE in 1 BOTTLE (68071-3877-5)
  • 60 CAPSULE in 1 BOTTLE (68071-3877-6)
source: ndc

Packages (3)

68071-3877-3 30 CAPSULE in 1 BOTTLE (68071-3877-3) 68071-3877-5 15 CAPSULE in 1 BOTTLE (68071-3877-5) 68071-3877-6 60 CAPSULE in 1 BOTTLE (68071-3877-6)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47acca00-4497-1432-e063-6294a90a7bc8", "openfda": {"upc": ["0368071387735"], "unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["3c323dc8-f734-b44c-e063-6394a90a6184"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68071-3877-3)", "package_ndc": "68071-3877-3", "marketing_start_date": "20250812"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE (68071-3877-5)", "package_ndc": "68071-3877-5", "marketing_start_date": "20260105"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68071-3877-6)", "package_ndc": "68071-3877-6", "marketing_start_date": "20250814"}], "brand_name": "Diphenhydramine HCl", "product_id": "68071-3877_47acca00-4497-1432-e063-6294a90a7bc8", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68071-3877", "generic_name": "Diphenhydramine HCl", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241206", "listing_expiration_date": "20271231"}