sleep

Generic: diphenhydramine hcl

Labeler: salado sales, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sleep
Generic Name diphenhydramine hcl
Labeler salado sales, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Salado Sales, Inc.

Identifiers & Regulatory

Product NDC 57243-189
Product ID 57243-189_ac0a5935-31a8-4bba-af05-3f7b8bf8eef9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 1990-04-10

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 57243189
Hyphenated Format 57243-189

Supplemental Identifiers

RxCUI
1049630
UPC
0761706166055
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 sleep (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (57243-189-21) / 8 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

57243-189-21 2 BLISTER PACK in 1 CARTON (57243-189-21) / 8 TABLET in 1 BLISTER PACK

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Sleep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ac0a5935-31a8-4bba-af05-3f7b8bf8eef9", "openfda": {"upc": ["0761706166055"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["837c02dd-971b-4451-98d8-9c438c9db696"], "manufacturer_name": ["Salado Sales, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (57243-189-21)  / 8 TABLET in 1 BLISTER PACK", "package_ndc": "57243-189-21", "marketing_start_date": "19900410"}], "brand_name": "Sleep", "product_id": "57243-189_ac0a5935-31a8-4bba-af05-3f7b8bf8eef9", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57243-189", "generic_name": "Diphenhydramine HCl", "labeler_name": "Salado Sales, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19900410", "listing_expiration_date": "20261231"}