diphenhydramine hcl oral solution

Generic: diphenhydramine hydrochloride

Labeler: natco pharma usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl oral solution
Generic Name diphenhydramine hydrochloride
Labeler natco pharma usa llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-151
Product ID 69339-151_6c998d25-3573-4c6b-822a-1c16eeddd642
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-12-14

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 69339151
Hyphenated Format 69339-151

Supplemental Identifiers

RxCUI
1049906
UPC
0369339152010 0369339151051
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 diphenhydramine hcl oral solution (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (69339-151-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)
  • 10 TRAY in 1 CASE (69339-151-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)
source: ndc

Packages (2)

69339-151-17 4 TRAY in 1 CASE (69339-151-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05) 69339-151-19 10 TRAY in 1 CASE (69339-151-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine HCl Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6c998d25-3573-4c6b-822a-1c16eeddd642", "openfda": {"upc": ["0369339152010", "0369339151051"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["54b64354-ac10-42ff-a53d-96cef933a91a"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (69339-151-17)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)", "package_ndc": "69339-151-17", "marketing_start_date": "20201214"}, {"sample": false, "description": "10 TRAY in 1 CASE (69339-151-19)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)", "package_ndc": "69339-151-19", "marketing_start_date": "20201214"}], "brand_name": "Diphenhydramine HCl Oral Solution", "product_id": "69339-151_6c998d25-3573-4c6b-822a-1c16eeddd642", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69339-151", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl Oral Solution", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201214", "listing_expiration_date": "20261231"}