topcare zzz sleep

Generic: diphenhydramine hcl

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare zzz sleep
Generic Name diphenhydramine hcl
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/30mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-200
Product ID 36800-200_b2891495-9d6a-4173-bf1b-a94d7747370c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2013-08-20

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 36800200
Hyphenated Format 36800-200

Supplemental Identifiers

RxCUI
1248354 1437306
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 topcare zzz sleep (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/30mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE (36800-200-40)
  • 2 BOTTLE in 1 PACKAGE (36800-200-50) / 355 mL in 1 BOTTLE
source: ndc

Packages (2)

36800-200-40 355 mL in 1 BOTTLE (36800-200-40) 36800-200-50 2 BOTTLE in 1 PACKAGE (36800-200-50) / 355 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (50 mg/30mL)

Linked Drug Pages (1)

Topcare ZZZ Sleep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b2891495-9d6a-4173-bf1b-a94d7747370c", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1248354", "1437306"], "spl_set_id": ["27225d04-6deb-436b-89ea-9842c487292e"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE (36800-200-40)", "package_ndc": "36800-200-40", "marketing_start_date": "20130820"}, {"sample": false, "description": "2 BOTTLE in 1 PACKAGE (36800-200-50)  / 355 mL in 1 BOTTLE", "package_ndc": "36800-200-50", "marketing_start_date": "20130820"}], "brand_name": "Topcare ZZZ Sleep", "product_id": "36800-200_b2891495-9d6a-4173-bf1b-a94d7747370c", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-200", "generic_name": "Diphenhydramine HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare ZZZ Sleep", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/30mL"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130820", "listing_expiration_date": "20261231"}