nighttime sleep aid

Generic: diphenhydramine hcl

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name diphenhydramine hcl
Labeler top care (topco associates llc)
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-116
Product ID 36800-116_f4be3bde-5fb8-42ec-a17b-1913624ec0da
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2020-01-31

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 36800116
Hyphenated Format 36800-116

Supplemental Identifiers

RxCUI
1020477
UPC
0036800114173
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
  • 1 BOTTLE, PLASTIC in 1 BOX (36800-116-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (36800-116-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

36800-116-32 1 BOTTLE, PLASTIC in 1 BOX (36800-116-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC 36800-116-64 1 BOTTLE, PLASTIC in 1 BOX (36800-116-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC

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": "f4be3bde-5fb8-42ec-a17b-1913624ec0da", "openfda": {"upc": ["0036800114173"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["027d7eff-6c83-40f1-9716-231637cdbeba"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (36800-116-32)  / 32 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "36800-116-32", "marketing_start_date": "20200131"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (36800-116-64)  / 64 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "36800-116-64", "marketing_start_date": "20200131"}], "brand_name": "Nighttime Sleep Aid", "product_id": "36800-116_f4be3bde-5fb8-42ec-a17b-1913624ec0da", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-116", "generic_name": "Diphenhydramine HCl", "labeler_name": "TOP CARE (Topco Associates LLC)", "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": "20200131", "listing_expiration_date": "20261231"}