nighttime sleep aid

Generic: diphenhydramine hcl

Labeler: wr group, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name diphenhydramine hcl
Labeler wr group, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
WR Group, Inc.

Identifiers & Regulatory

Product NDC 69607-0916
Product ID 69607-0916_b1a15331-6c20-494d-9c50-a27f4702aaa6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2021-08-06

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 696070916
Hyphenated Format 69607-0916

Supplemental Identifiers

RxCUI
1020477
UPC
0811079035240
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 hcl (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 96 CAPSULE in 1 BOTTLE, PLASTIC (69607-0916-6)
source: ndc

Packages (1)

69607-0916-6 96 CAPSULE in 1 BOTTLE, PLASTIC (69607-0916-6)

Ingredients (1)

diphenhydramine hydrochloride (50 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": "b1a15331-6c20-494d-9c50-a27f4702aaa6", "openfda": {"upc": ["0811079035240"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["d28d0f6d-8029-4e31-b417-4f8f864d840e"], "manufacturer_name": ["WR Group, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "96 CAPSULE in 1 BOTTLE, PLASTIC (69607-0916-6)", "package_ndc": "69607-0916-6", "marketing_start_date": "20210806"}], "brand_name": "Nighttime Sleep Aid", "product_id": "69607-0916_b1a15331-6c20-494d-9c50-a27f4702aaa6", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69607-0916", "generic_name": "Diphenhydramine HCl", "labeler_name": "WR Group, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210806", "listing_expiration_date": "20261231"}