sleepaid softgels

Generic: diphenhydramine hydrochloride

Labeler: nuvicare llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sleepaid softgels
Generic Name diphenhydramine hydrochloride
Labeler nuvicare llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
NUVICARE LLC

Identifiers & Regulatory

Product NDC 84324-011
Product ID 84324-011_26f01c7e-1666-482a-9701-157642a3f431
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2024-07-17

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 84324011
Hyphenated Format 84324-011

Supplemental Identifiers

RxCUI
1020477
UPC
0384324000091
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 sleepaid softgels (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-011-01)
source: ndc

Packages (1)

84324-011-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-011-01)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

SleepAid Softgels ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26f01c7e-1666-482a-9701-157642a3f431", "openfda": {"upc": ["0384324000091"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["963c6925-dfbf-4cdc-8d13-5e10b499c4a9"], "manufacturer_name": ["NUVICARE LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-011-01)", "package_ndc": "84324-011-01", "marketing_start_date": "20240717"}], "brand_name": "SleepAid Softgels", "product_id": "84324-011_26f01c7e-1666-482a-9701-157642a3f431", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "84324-011", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "NUVICARE LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SleepAid Softgels", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240717", "listing_expiration_date": "20261231"}