onessip diphenhydramine hcl 12.5 mg/ 5 ml oral solution

Generic: diphenhydramine hcl

Labeler: medwise lifesciences inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name onessip diphenhydramine hcl 12.5 mg/ 5 ml oral solution
Generic Name diphenhydramine hcl
Labeler medwise lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
MEDWISE LIFESCIENCES INC.

Identifiers & Regulatory

Product NDC 87078-411
Product ID 87078-411_407b7cbb-7ebe-7b7e-e063-6394a90af501
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-10-06

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 87078411
Hyphenated Format 87078-411

Supplemental Identifiers

RxCUI
1049906
UPC
0850078212009
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 onessip diphenhydramine hcl 12.5 mg/ 5 ml oral solution (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (87078-411-52) / 5 mL in 1 POUCH
source: ndc

Packages (1)

87078-411-52 12 POUCH in 1 CARTON (87078-411-52) / 5 mL in 1 POUCH

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "407b7cbb-7ebe-7b7e-e063-6394a90af501", "openfda": {"upc": ["0850078212009"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["407b7cbb-7ebd-7b7e-e063-6394a90af501"], "manufacturer_name": ["MEDWISE LIFESCIENCES INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (87078-411-52)  / 5 mL in 1 POUCH", "package_ndc": "87078-411-52", "marketing_start_date": "20251006"}], "brand_name": "OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution", "product_id": "87078-411_407b7cbb-7ebe-7b7e-e063-6394a90af501", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "87078-411", "generic_name": "Diphenhydramine HCl", "labeler_name": "MEDWISE LIFESCIENCES INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251006", "listing_expiration_date": "20261231"}