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 LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/30mL

Manufacturer
BJWC (Berkley & Jensen / BJ's)

Identifiers & Regulatory

Product NDC 68391-793
Product ID 68391-793_3c140f45-e3b1-9bcd-e063-6394a90acd8b
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 68391793
Hyphenated Format 68391-793

Supplemental Identifiers

RxCUI
1248354
UPC
0888670204061
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
  • 50 mg/30mL
source: ndc
Packaging
  • 3 BOTTLE in 1 PACKAGE (68391-793-09) / 354 mL in 1 BOTTLE (68391-793-01)
source: ndc

Packages (1)

68391-793-09 3 BOTTLE in 1 PACKAGE (68391-793-09) / 354 mL in 1 BOTTLE (68391-793-01)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/30mL)

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": "3c140f45-e3b1-9bcd-e063-6394a90acd8b", "openfda": {"upc": ["0888670204061"], "unii": ["TC2D6JAD40"], "rxcui": ["1248354"], "spl_set_id": ["2f477706-0ce2-97b0-e063-6294a90a5c8e"], "manufacturer_name": ["BJWC (Berkley & Jensen / BJ's)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 PACKAGE (68391-793-09)  / 354 mL in 1 BOTTLE (68391-793-01)", "package_ndc": "68391-793-09", "marketing_start_date": "20250820"}], "brand_name": "Nighttime Sleep Aid", "product_id": "68391-793_3c140f45-e3b1-9bcd-e063-6394a90acd8b", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68391-793", "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": "50 mg/30mL"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250820", "listing_expiration_date": "20261231"}