nighttime sleep aid

Generic: diphenhydramine hydrochloride

Labeler: bjwc (berkley & jensen / bj's)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name diphenhydramine hydrochloride
Labeler bjwc (berkley & jensen / bj's)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
BJWC (Berkley & Jensen / BJ's)

Identifiers & Regulatory

Product NDC 68391-613
Product ID 68391-613_3c10ec86-2536-00f5-e063-6394a90a244c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2025-08-20

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 68391613
Hyphenated Format 68391-613

Supplemental Identifiers

RxCUI
1049909
UPC
0888670204009
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 nighttime sleep aid (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 16 BLISTER PACK in 1 CARTON (68391-613-92) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

68391-613-92 16 BLISTER PACK in 1 CARTON (68391-613-92) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Nighttime Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3c10ec86-2536-00f5-e063-6394a90a244c", "openfda": {"upc": ["0888670204009"], "unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["2f476647-5727-3443-e063-6394a90afd3f"], "manufacturer_name": ["BJWC (Berkley & Jensen / BJ's)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 BLISTER PACK in 1 CARTON (68391-613-92)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "68391-613-92", "marketing_start_date": "20250820"}], "brand_name": "Nighttime Sleep Aid", "product_id": "68391-613_3c10ec86-2536-00f5-e063-6394a90a244c", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68391-613", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "BJWC (Berkley & Jensen / BJ's)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250820", "listing_expiration_date": "20261231"}